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Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES) (SPRITES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01302080
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : October 8, 2021
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Obsessive Compulsive Disorder
Interventions Drug: sertraline
Behavioral: psychotherapy
Enrollment 941
Recruitment Details This was a non-interventional observational study. Participants to be enrolled were of age 6 to 16 (inclusive), exposed to sertraline (with or without psychotherapy) and exposed to psychotherapy alone under real world conditions. Participants exposed and unexposed to sertraline were followed for a maximum of 3 years.
Pre-assignment Details Participants switched from 1 treatment to another throughout the study, irrespective in which arm they were enrolled. Hence, number of participants for reporting arms were different at different visits.
Arm/Group Title Sertraline Psychotherapy
Hide Arm/Group Description Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to United States prescribing information (USPI) provided by their physician. Participants in this group were on sertraline only or sertraline and any other treatment. Treatment here was the one which was planned for the participants at baseline. Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial/psychotherapy rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a selective serotonin reuptake inhibitor (SSRI) medication. Participants in this group were on psychotherapy only or no treatment at all.
Period Title: Overall Study
Started 696 [1] 245 [2]
Completed 330 102
Not Completed 366 143
Reason Not Completed
Withdrew Consent             92             39
Patient/Family Moved             28             3
Lost to Follow-up             192             93
Death             1             0
Other             52             8
Reason Missing For Discontinuation             1             0
[1]
Out of 696 participants, 1 participant started treatment with another antidepressant alone or along with psychotherapy.
[2]
Out of 245 participants, 2 participants started treatment with another antidepressant alone or along with psychotherapy.
Arm/Group Title Sertraline Other Antidepressant Psychotherapy Total
Hide Arm/Group Description Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. Use of other antidepressants at baseline was a study exclusion criterion, however, a few participants were enrolled who initiated treatment with an antidepressant. Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. Total of all reporting groups
Overall Number of Baseline Participants 695 3 243 941
Hide Baseline Analysis Population Description
Analysis population included all participants in the database who had informed consent.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 695 participants 3 participants 243 participants 941 participants
12.2  (2.9) 14.0  (3.0) 11.0  (2.9) 11.9  (2.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 695 participants 3 participants 243 participants 941 participants
Female
405
  58.3%
3
 100.0%
130
  53.5%
538
  57.2%
Male
290
  41.7%
0
   0.0%
113
  46.5%
403
  42.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 695 participants 3 participants 243 participants 941 participants
Hispanic or Latino
73
  10.5%
1
  33.3%
24
   9.9%
98
  10.4%
Not Hispanic or Latino
622
  89.5%
2
  66.7%
219
  90.1%
843
  89.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 695 participants 3 participants 243 participants 941 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
23
   3.3%
0
   0.0%
2
   0.8%
25
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
66
   9.5%
0
   0.0%
15
   6.2%
81
   8.6%
White
588
  84.6%
3
 100.0%
208
  85.6%
799
  84.9%
More than one race
14
   2.0%
0
   0.0%
13
   5.3%
27
   2.9%
Unknown or Not Reported
4
   0.6%
0
   0.0%
5
   2.1%
9
   1.0%
1.Primary Outcome
Title Change From Baseline in Cognitive Function Using Trails B at Month 3
Hide Description Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:

At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician.

At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 666 3 224
Mean (Standard Deviation)
Unit of Measure: Z-score
Baseline Number Analyzed 666 participants 3 participants 224 participants
1.03  (2.3) 1.23  (1.0) 0.61  (1.8)
Change at Week 3 Number Analyzed 527 participants 3 participants 163 participants
-0.39  (1.6) -0.09  (0.5) -0.03  (2.3)
2.Primary Outcome
Title Change From Baseline in Cognitive Function Using Trails B at Month 6
Hide Description Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 460 35 159
Mean (Standard Deviation)
Unit of Measure: Z-score
-0.64  (2.2) -0.65  (1.0) -0.16  (1.9)
3.Primary Outcome
Title Change From Baseline in Cognitive Function Using Trails B at Month 12
Hide Description Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 367 57 138
Mean (Standard Deviation)
Unit of Measure: Z-score
-0.72  (2.3) -0.22  (1.4) -0.27  (2.4)
4.Primary Outcome
Title Change From Baseline in Cognitive Function Using Trails B at Month 18
Hide Description Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time Frame Baseline, Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 290 70 138
Mean (Standard Deviation)
Unit of Measure: Z-score
-0.57  (1.9) -0.65  (2.2) -0.22  (2.8)
5.Primary Outcome
Title Change From Baseline in Cognitive Function Using Trails B at Month 24
Hide Description Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 247 70 134
Mean (Standard Deviation)
Unit of Measure: Z-score
-0.44  (2.2) -1.08  (1.7) -0.18  (3.4)
6.Primary Outcome
Title Change From Baseline in Cognitive Function Using Trails B at Month 30
Hide Description Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time Frame Baseline, Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 209 63 141
Mean (Standard Deviation)
Unit of Measure: Z-score
-0.74  (2.1) -0.61  (2.4) -0.18  (4.2)
7.Primary Outcome
Title Change From Baseline in Cognitive Function Using Trails B at Month 36
Hide Description Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 193 56 154
Mean (Standard Deviation)
Unit of Measure: Z-score
-0.25  (2.9) -0.13  (3.6) -0.59  (2.6)
8.Primary Outcome
Title Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3
Hide Description BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 686 3 237
Mean (Standard Deviation)
Unit of Measure: Z-score
Baseline Number Analyzed 686 participants 3 participants 237 participants
62.93  (11.3) 57.67  (5.5) 59.27  (13.0)
Change at Week 3 Number Analyzed 539 participants 2 participants 170 participants
-2.29  (7.8) 4.50  (13.4) -1.88  (7.3)
9.Primary Outcome
Title Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6
Hide Description BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 467 35 166
Mean (Standard Deviation)
Unit of Measure: Z-score
-2.53  (8.8) -1.54  (8.8) -2.74  (8.7)
10.Primary Outcome
Title Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12
Hide Description BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 370 58 140
Mean (Standard Deviation)
Unit of Measure: Z-score
-3.12  (9.1) -1.97  (8.3) -2.81  (9.0)
11.Primary Outcome
Title Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18
Hide Description BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame Baseline, Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 290 69 140
Mean (Standard Deviation)
Unit of Measure: Z-score
-2.40  (9.2) -1.57  (9.9) -3.13  (8.3)
12.Primary Outcome
Title Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24
Hide Description BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 248 66 133
Mean (Standard Deviation)
Unit of Measure: Z-score
-3.37  (10.0) -3.14  (9.0) -4.16  (9.5)
13.Primary Outcome
Title Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30
Hide Description BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame Baseline, Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 200 59 135
Mean (Standard Deviation)
Unit of Measure: Z-score
-3.60  (11.2) -4.39  (8.7) -4.53  (10.2)
14.Primary Outcome
Title Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36
Hide Description BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 184 54 141
Mean (Standard Deviation)
Unit of Measure: Z-score
-3.96  (12.1) -3.87  (10.4) -4.62  (10.9)
15.Primary Outcome
Title Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3
Hide Description BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 692 3 238
Mean (Standard Deviation)
Unit of Measure: Z-score
Baseline Number Analyzed 692 participants 3 participants 238 participants
65.15  (12.0) 58.67  (4.0) 61.88  (12.6)
Change at Week 3 Number Analyzed 544 participants 2 participants 171 participants
-3.08  (9.1) -1.50  (0.7) -2.39  (7.4)
16.Primary Outcome
Title Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6
Hide Description BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 472 36 167
Mean (Standard Deviation)
Unit of Measure: Z-score
-4.06  (9.4) -3.14  (9.7) -3.62  (8.9)
17.Primary Outcome
Title Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12
Hide Description BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 373 59 140
Mean (Standard Deviation)
Unit of Measure: Z-score
-5.42  (10.1) -2.44  (8.2) -5.01  (9.5)
18.Primary Outcome
Title Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18
Hide Description BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame Baseline, Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 294 71 140
Mean (Standard Deviation)
Unit of Measure: Z-score
-5.21  (9.9) -3.59  (9.9) -4.48  (9.2)
19.Primary Outcome
Title Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24
Hide Description BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 252 68 133
Mean (Standard Deviation)
Unit of Measure: Z-score
-6.21  (11.2) -5.78  (8.8) -6.05  (9.9)
20.Primary Outcome
Title Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30
Hide Description BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame Baseline, Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 204 61 136
Mean (Standard Deviation)
Unit of Measure: Z-score
-6.92  (10.8) -5.23  (10.0) -6.53  (10.4)
21.Primary Outcome
Title Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36
Hide Description BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 188 55 142
Mean (Standard Deviation)
Unit of Measure: Z-score
-7.44  (11.1) -7.24  (10.6) -6.22  (11.2)
22.Primary Outcome
Title Change From Baseline in Height at Month 3
Hide Description Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on centers for disease control (CDC) norms for age and gender.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 693 3 243
Mean (Standard Deviation)
Unit of Measure: Z-score
Baseline Number Analyzed 693 participants 3 participants 243 participants
0.31  (1.1) 0.76  (1.4) 0.32  (1.1)
Change at Month 3 Number Analyzed 554 participants 3 participants 174 participants
0.00  (0.3) -0.03  (0.1) -0.01  (0.3)
23.Primary Outcome
Title Change From Baseline in Height at Month 6
Hide Description Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 478 36 170
Mean (Standard Deviation)
Unit of Measure: Z-score
-0.02  (0.3) 0.07  (0.4) 0.00  (0.4)
24.Primary Outcome
Title Change From Baseline in Height at Month 12
Hide Description Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 381 59 144
Mean (Standard Deviation)
Unit of Measure: Z-score
-0.01  (0.4) 0.06  (0.5) -0.04  (0.4)
25.Primary Outcome
Title Change From Baseline in Height at Month 18
Hide Description Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 305 74 145
Mean (Standard Deviation)
Unit of Measure: Z-score
-0.03  (0.5) 0.00  (0.5) -0.02  (0.6)
26.Primary Outcome
Title Change From Baseline in Height at Month 24
Hide Description Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 263 70 138
Mean (Standard Deviation)
Unit of Measure: Z-score
0.01  (0.5) -0.02  (0.6) -0.02  (0.5)
27.Primary Outcome
Title Change From Baseline in Height at Month 30
Hide Description Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 218 66 148
Mean (Standard Deviation)
Unit of Measure: Z-score
0.01  (0.7) -0.10  (0.6) 0.00  (0.6)
28.Primary Outcome
Title Change From Baseline in Height at Month 36
Hide Description Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 203 62 160
Mean (Standard Deviation)
Unit of Measure: Z-score
0.00  (0.7) -0.04  (0.7) -0.02  (0.9)
29.Primary Outcome
Title Change From Baseline in Weight at Month 3
Hide Description Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 693 3 243
Mean (Standard Deviation)
Unit of Measure: Z-score
Baseline Number Analyzed 693 participants 3 participants 243 participants
0.58  (1.2) 0.88  (0.7) 0.42  (1.0)
Change at Month 3 Number Analyzed 554 participants 3 participants 173 participants
0.02  (0.2) -0.22  (0.1) -0.03  (0.2)
30.Primary Outcome
Title Change From Baseline in Weight at Month 6
Hide Description Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 478 36 170
Mean (Standard Deviation)
Unit of Measure: Z-score
0.03  (0.3) 0.01  (0.3) -0.05  (0.3)
31.Primary Outcome
Title Change From Baseline in Weight at Month 12
Hide Description Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 382 59 144
Mean (Standard Deviation)
Unit of Measure: Z-score
0.10  (0.4) 0.06  (0.5) 0.00  (0.4)
32.Primary Outcome
Title Change From Baseline in Weight at Month 18
Hide Description Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 305 74 145
Mean (Standard Deviation)
Unit of Measure: Z-score
0.14  (0.5) 0.07  (0.6) -0.01  (0.5)
33.Primary Outcome
Title Change From Baseline in Weight at Month 24
Hide Description Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 263 70 138
Mean (Standard Deviation)
Unit of Measure: Z-score
0.16  (0.5) 0.15  (0.6) 0.00  (0.6)
34.Primary Outcome
Title Change From Baseline in Weight at Month 30
Hide Description Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 218 66 148
Mean (Standard Deviation)
Unit of Measure: Z-score
0.16  (0.6) 0.11  (0.6) 0.04  (0.6)
35.Primary Outcome
Title Change From Baseline in Weight at Month 36
Hide Description Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 203 62 162
Mean (Standard Deviation)
Unit of Measure: Z-score
0.17  (0.6) 0.17  (0.7) 0.02  (0.6)
36.Primary Outcome
Title Change From Baseline in Body Mass Index (BMI) at Month 3
Hide Description BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 693 3 243
Mean (Standard Deviation)
Unit of Measure: Z-score
Baseline Number Analyzed 693 participants 3 participants 243 participants
0.48  (1.3) 0.79  (0.4) 0.27  (1.3)
Change at Month 3 Number Analyzed 554 participants 3 participants 173 participants
0.02  (0.3) -0.26  (0.2) -0.03  (0.3)
37.Primary Outcome
Title Change From Baseline in Body Mass Index (BMI) at Month 6
Hide Description BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 478 36 170
Mean (Standard Deviation)
Unit of Measure: Z-score
0.04  (0.4) -0.03  (0.4) -0.06  (0.4)
38.Primary Outcome
Title Change From Baseline in Body Mass Index (BMI) at Month 12
Hide Description BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 381 59 144
Mean (Standard Deviation)
Unit of Measure: Z-score
0.13  (0.5) 0.06  (0.6) 0.04  (0.6)
39.Primary Outcome
Title Change From Baseline in Body Mass Index (BMI) at Month 18
Hide Description BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 305 74 145
Mean (Standard Deviation)
Unit of Measure: Z-score
0.18  (0.6) 0.07  (0.8) -0.04  (0.6)
40.Primary Outcome
Title Change From Baseline in Body Mass Index (BMI) at Month 24
Hide Description BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 263 70 138
Mean (Standard Deviation)
Unit of Measure: Z-score
0.17  (0.7) 0.20  (0.9) -0.01  (0.7)
41.Primary Outcome
Title Change From Baseline in Body Mass Index (BMI) at Month 30
Hide Description BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 218 66 148
Mean (Standard Deviation)
Unit of Measure: Z-score
0.16  (0.8) 0.15  (0.8) 0.03  (0.7)
42.Primary Outcome
Title Change From Baseline in Body Mass Index (BMI) at Month 36
Hide Description BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time Frame Baseline, Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 203 62 160
Mean (Standard Deviation)
Unit of Measure: Z-score
0.17  (0.8) 0.21  (0.9) 0.01  (0.7)
43.Primary Outcome
Title Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure. There were no male participants in reporting arm "Other Antidepressant" at Baseline, hence no data collected and evaluated.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 288 0 113
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
122
  42.4%
58
  51.3%
Stage 2
53
  18.4%
20
  17.7%
Stage 3
45
  15.6%
17
  15.0%
Stage 4
53
  18.4%
15
  13.3%
Stage 5
15
   5.2%
3
   2.7%
44.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 3: All Males
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 230 1 80
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
94
  40.9%
1
 100.0%
42
  52.5%
Stage 2
40
  17.4%
0
   0.0%
10
  12.5%
Stage 3
43
  18.7%
0
   0.0%
14
  17.5%
Stage 4
45
  19.6%
0
   0.0%
11
  13.8%
Stage 5
8
   3.5%
0
   0.0%
3
   3.8%
45.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 6: All Males
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 203 14 77
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
75
  36.9%
6
  42.9%
36
  46.8%
Stage 2
44
  21.7%
2
  14.3%
11
  14.3%
Stage 3
34
  16.7%
3
  21.4%
14
  18.2%
Stage 4
43
  21.2%
2
  14.3%
14
  18.2%
Stage 5
7
   3.4%
1
   7.1%
2
   2.6%
46.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 12: All Males
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 164 24 69
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
55
  33.5%
7
  29.2%
30
  43.5%
Stage 2
37
  22.6%
2
   8.3%
11
  15.9%
Stage 3
26
  15.9%
5
  20.8%
12
  17.4%
Stage 4
36
  22.0%
8
  33.3%
12
  17.4%
Stage 5
10
   6.1%
2
   8.3%
4
   5.8%
47.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 18: All Males
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 136 33 57
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
39
  28.7%
9
  27.3%
20
  35.1%
Stage 2
31
  22.8%
5
  15.2%
11
  19.3%
Stage 3
19
  14.0%
6
  18.2%
12
  21.1%
Stage 4
33
  24.3%
7
  21.2%
9
  15.8%
Stage 5
14
  10.3%
6
  18.2%
5
   8.8%
48.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 24: All Males
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 112 34 62
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
32
  28.6%
7
  20.6%
13
  21.0%
Stage 2
27
  24.1%
9
  26.5%
12
  19.4%
Stage 3
17
  15.2%
6
  17.6%
14
  22.6%
Stage 4
22
  19.6%
6
  17.6%
16
  25.8%
Stage 5
14
  12.5%
6
  17.6%
7
  11.3%
49.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 30: All Males
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 86 33 64
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
23
  26.7%
5
  15.2%
10
  15.6%
Stage 2
18
  20.9%
7
  21.2%
8
  12.5%
Stage 3
16
  18.6%
5
  15.2%
19
  29.7%
Stage 4
15
  17.4%
6
  18.2%
19
  29.7%
Stage 5
14
  16.3%
10
  30.3%
8
  12.5%
50.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 36: All Males
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of male participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 84 34 75
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
18
  21.4%
6
  17.6%
7
   9.3%
Stage 2
18
  21.4%
4
  11.8%
12
  16.0%
Stage 3
14
  16.7%
10
  29.4%
15
  20.0%
Stage 4
22
  26.2%
4
  11.8%
25
  33.3%
Stage 5
12
  14.3%
10
  29.4%
16
  21.3%
51.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Baseline: All Females
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 401 3 130
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
81
  20.2%
1
  33.3%
39
  30.0%
Stage 2
40
  10.0%
0
   0.0%
21
  16.2%
Stage 3
61
  15.2%
0
   0.0%
25
  19.2%
Stage 4
146
  36.4%
1
  33.3%
28
  21.5%
Stage 5
73
  18.2%
1
  33.3%
17
  13.1%
52.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 3: All Females
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 323 2 94
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
59
  18.3%
1
  50.0%
30
  31.9%
Stage 2
37
  11.5%
0
   0.0%
13
  13.8%
Stage 3
47
  14.6%
0
   0.0%
14
  14.9%
Stage 4
108
  33.4%
0
   0.0%
24
  25.5%
Stage 5
72
  22.3%
1
  50.0%
13
  13.8%
53.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 6: All Females
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 275 22 91
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
43
  15.6%
1
   4.5%
22
  24.2%
Stage 2
31
  11.3%
4
  18.2%
13
  14.3%
Stage 3
46
  16.7%
2
   9.1%
18
  19.8%
Stage 4
90
  32.7%
10
  45.5%
18
  19.8%
Stage 5
65
  23.6%
5
  22.7%
20
  22.0%
54.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 12: All Females
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 218 35 75
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
27
  12.4%
5
  14.3%
9
  12.0%
Stage 2
27
  12.4%
2
   5.7%
15
  20.0%
Stage 3
31
  14.2%
5
  14.3%
12
  16.0%
Stage 4
71
  32.6%
11
  31.4%
24
  32.0%
Stage 5
62
  28.4%
12
  34.3%
15
  20.0%
55.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 18: All Females
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 169 40 88
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
17
  10.1%
4
  10.0%
9
  10.2%
Stage 2
14
   8.3%
2
   5.0%
14
  15.9%
Stage 3
22
  13.0%
2
   5.0%
13
  14.8%
Stage 4
57
  33.7%
14
  35.0%
31
  35.2%
Stage 5
59
  34.9%
18
  45.0%
21
  23.9%
56.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 24: All Females
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 151 37 76
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
13
   8.6%
2
   5.4%
8
  10.5%
Stage 2
15
   9.9%
3
   8.1%
10
  13.2%
Stage 3
16
  10.6%
1
   2.7%
13
  17.1%
Stage 4
49
  32.5%
11
  29.7%
24
  31.6%
Stage 5
58
  38.4%
20
  54.1%
21
  27.6%
57.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 30: All Females
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Month 30
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 132 33 84
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
10
   7.6%
1
   3.0%
3
   3.6%
Stage 2
15
  11.4%
2
   6.1%
9
  10.7%
Stage 3
15
  11.4%
1
   3.0%
8
   9.5%
Stage 4
34
  25.8%
8
  24.2%
29
  34.5%
Stage 5
58
  43.9%
21
  63.6%
35
  41.7%
58.Primary Outcome
Title Number of Participants With Tanner Staging Evaluation at Month 36: All Females
Hide Description Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of female participants evaluable for this outcome measure.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 120 30 88
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
9
   7.5%
0
   0.0%
2
   2.3%
Stage 2
9
   7.5%
2
   6.7%
9
  10.2%
Stage 3
9
   7.5%
7
  23.3%
8
   9.1%
Stage 4
32
  26.7%
7
  23.3%
25
  28.4%
Stage 5
61
  50.8%
14
  46.7%
44
  50.0%
59.Secondary Outcome
Title Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36
Hide Description CGI-I scale was a 7-point scale used to rate improvement in the participant's condition (benefits). Scale range/categories: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = Not changed, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher score indicated worse condition.
Time Frame Month 3, 6, 12, 18, 24, 30 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 556 73 176
Measure Type: Count of Participants
Unit of Measure: Participants
Month 3 Number Analyzed 556 participants 3 participants 176 participants
Very Much Improved
77
  13.8%
0
   0.0%
17
   9.7%
Much Improved
223
  40.1%
0
   0.0%
51
  29.0%
Minimally Improved
151
  27.2%
1
  33.3%
69
  39.2%
Not Changed
63
  11.3%
1
  33.3%
29
  16.5%
Minimally Worse
20
   3.6%
0
   0.0%
3
   1.7%
Much Worse
21
   3.8%
0
   0.0%
5
   2.8%
Very Much Worse
1
   0.2%
1
  33.3%
2
   1.1%
Month 6 Number Analyzed 478 participants 34 participants 167 participants
Very Much Improved
96
  20.1%
2
   5.9%
29
  17.4%
Much Improved
220
  46.0%
14
  41.2%
64
  38.3%
Minimally Improved
87
  18.2%
7
  20.6%
48
  28.7%
Not Changed
44
   9.2%
8
  23.5%
21
  12.6%
Minimally Worse
15
   3.1%
0
   0.0%
2
   1.2%
Much Worse
12
   2.5%
3
   8.8%
2
   1.2%
Very Much Worse
4
   0.8%
0
   0.0%
1
   0.6%
Month 12 Number Analyzed 382 participants 57 participants 141 participants
Very Much Improved
93
  24.3%
9
  15.8%
32
  22.7%
Much Improved
174
  45.5%
19
  33.3%
55
  39.0%
Minimally Improved
80
  20.9%
20
  35.1%
28
  19.9%
Not Changed
16
   4.2%
6
  10.5%
18
  12.8%
Minimally Worse
7
   1.8%
1
   1.8%
2
   1.4%
Much Worse
9
   2.4%
2
   3.5%
6
   4.3%
Very Much Worse
3
   0.8%
0
   0.0%
0
   0.0%
Month 18 Number Analyzed 304 participants 73 participants 139 participants
Very Much Improved
86
  28.3%
14
  19.2%
32
  23.0%
Much Improved
136
  44.7%
34
  46.6%
55
  39.6%
Minimally Improved
53
  17.4%
11
  15.1%
34
  24.5%
Not Changed
14
   4.6%
10
  13.7%
11
   7.9%
Minimally Worse
6
   2.0%
1
   1.4%
2
   1.4%
Much Worse
7
   2.3%
2
   2.7%
5
   3.6%
Very Much Worse
2
   0.7%
1
   1.4%
0
   0.0%
Month 24 Number Analyzed 262 participants 70 participants 130 participants
Very Much Improved
93
  35.5%
10
  14.3%
34
  26.2%
Much Improved
113
  43.1%
39
  55.7%
53
  40.8%
Minimally Improved
34
  13.0%
10
  14.3%
27
  20.8%
Not Changed
16
   6.1%
9
  12.9%
9
   6.9%
Minimally Worse
5
   1.9%
2
   2.9%
2
   1.5%
Much Worse
0
   0.0%
0
   0.0%
4
   3.1%
Very Much Worse
1
   0.4%
0
   0.0%
1
   0.8%
Month 30 Number Analyzed 214 participants 64 participants 143 participants
Very Much Improved
73
  34.1%
12
  18.8%
43
  30.1%
Much Improved
102
  47.7%
41
  64.1%
63
  44.1%
Minimally Improved
21
   9.8%
8
  12.5%
23
  16.1%
Not Changed
12
   5.6%
2
   3.1%
12
   8.4%
Minimally Worse
4
   1.9%
1
   1.6%
1
   0.7%
Much Worse
1
   0.5%
0
   0.0%
1
   0.7%
Very Much Worse
1
   0.5%
0
   0.0%
0
   0.0%
Month 36 Number Analyzed 203 participants 64 participants 154 participants
Very Much Improved
85
  41.9%
22
  34.4%
53
  34.4%
Much Improved
85
  41.9%
27
  42.2%
77
  50.0%
Minimally Improved
22
  10.8%
9
  14.1%
15
   9.7%
Not Changed
5
   2.5%
3
   4.7%
8
   5.2%
Minimally Worse
1
   0.5%
1
   1.6%
1
   0.6%
Much Worse
4
   2.0%
2
   3.1%
0
   0.0%
Very Much Worse
1
   0.5%
0
   0.0%
0
   0.0%
60.Secondary Outcome
Title Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36
Hide Description CGI-T scale was a 7-point scale used to assess the tolerability of the study medication with respect to adverse events. Scale range/categories: 1= very high, 2= high, 3= above average, 4= average, 5= low, 6= very low, and 7= extremely low. Higher score indicated less tolerability with study medication.
Time Frame Month 3, 6, 12, 18, 24, 30 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 546 65 96
Measure Type: Count of Participants
Unit of Measure: Participants
Month 3 Number Analyzed 546 participants 2 participants 96 participants
Very High
274
  50.2%
0
   0.0%
25
  26.0%
High
123
  22.5%
0
   0.0%
18
  18.8%
Above Average
40
   7.3%
0
   0.0%
18
  18.8%
Average
69
  12.6%
2
 100.0%
30
  31.3%
Low
22
   4.0%
0
   0.0%
3
   3.1%
Very Low
10
   1.8%
0
   0.0%
2
   2.1%
Extremely Low
8
   1.5%
0
   0.0%
0
   0.0%
Month 6 Number Analyzed 468 participants 29 participants 95 participants
Very High
245
  52.4%
14
  48.3%
33
  34.7%
High
116
  24.8%
4
  13.8%
12
  12.6%
Above Average
28
   6.0%
1
   3.4%
20
  21.1%
Average
49
  10.5%
6
  20.7%
23
  24.2%
Low
19
   4.1%
2
   6.9%
2
   2.1%
Very Low
5
   1.1%
1
   3.4%
4
   4.2%
Extremely Low
6
   1.3%
1
   3.4%
1
   1.1%
Month 12 Number Analyzed 367 participants 52 participants 74 participants
Very High
217
  59.1%
23
  44.2%
30
  40.5%
High
84
  22.9%
12
  23.1%
14
  18.9%
Above Average
19
   5.2%
3
   5.8%
12
  16.2%
Average
35
   9.5%
10
  19.2%
14
  18.9%
Low
11
   3.0%
4
   7.7%
4
   5.4%
Very Low
1
   0.3%
0
   0.0%
0
   0.0%
Extremely Low
0
   0.0%
0
   0.0%
0
   0.0%
Month 18 Number Analyzed 298 participants 64 participants 69 participants
Very High
170
  57.0%
32
  50.0%
35
  50.7%
High
77
  25.8%
15
  23.4%
9
  13.0%
Above Average
16
   5.4%
3
   4.7%
7
  10.1%
Average
26
   8.7%
10
  15.6%
11
  15.9%
Low
5
   1.7%
3
   4.7%
6
   8.7%
Very Low
2
   0.7%
0
   0.0%
0
   0.0%
Extremely Low
2
   0.7%
1
   1.6%
1
   1.4%
Month 24 Number Analyzed 250 participants 65 participants 60 participants
Very High
149
  59.6%
37
  56.9%
33
  55.0%
High
67
  26.8%
17
  26.2%
12
  20.0%
Above Average
9
   3.6%
5
   7.7%
3
   5.0%
Average
19
   7.6%
3
   4.6%
8
  13.3%
Low
4
   1.6%
3
   4.6%
4
   6.7%
Very Low
2
   0.8%
0
   0.0%
0
   0.0%
Extremely Low
0
   0.0%
0
   0.0%
0
   0.0%
Month 30 Number Analyzed 210 participants 59 participants 57 participants
Very High
132
  62.9%
29
  49.2%
35
  61.4%
High
55
  26.2%
18
  30.5%
5
   8.8%
Above Average
7
   3.3%
6
  10.2%
6
  10.5%
Average
12
   5.7%
5
   8.5%
9
  15.8%
Low
2
   1.0%
1
   1.7%
1
   1.8%
Very Low
1
   0.5%
0
   0.0%
1
   1.8%
Extremely Low
1
   0.5%
0
   0.0%
0
   0.0%
Month 36 Number Analyzed 197 participants 56 participants 58 participants
Very High
125
  63.5%
35
  62.5%
32
  55.2%
High
51
  25.9%
12
  21.4%
10
  17.2%
Above Average
11
   5.6%
3
   5.4%
6
  10.3%
Average
7
   3.6%
5
   8.9%
7
  12.1%
Low
0
   0.0%
1
   1.8%
2
   3.4%
Very Low
1
   0.5%
0
   0.0%
0
   0.0%
Extremely Low
2
   1.0%
0
   0.0%
1
   1.7%
61.Secondary Outcome
Title Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36
Hide Description The CGI-E was the value at which the participant's therapeutic benefit and adverse impact to the study drug intersected. Firstly clinician identified the degree of therapeutic benefit on scale range: very much improved, much improved, minimally improved, unchanged or worse. Secondly, the clinician rater identified the degree to which problems with tolerability adversely impact the participant on scale range: no adverse impact, mild adverse impact, moderate adverse impact, outweighs therapeutic effect. Finally, clinician identified in which participants benefits and adverse impacts intersected. Participants were then determined to be responders or non-responders to the study medication.
Time Frame Month 3, 6, 12, 18, 24, 30 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 544 67 130
Measure Type: Count of Participants
Unit of Measure: Participants
Responders at Month 3 Number Analyzed 544 participants 2 participants 130 participants
296 1 55
Responders at Month 6 Number Analyzed 470 participants 30 participants 120 participants
309 14 72
Responders at Month 12 Number Analyzed 372 participants 53 participants 91 participants
268 28 52
Responders at Month 18 Number Analyzed 300 participants 65 participants 87 participants
219 44 54
Responders at Month 24 Number Analyzed 255 participants 67 participants 75 participants
206 47 54
Responders at Month 30 Number Analyzed 212 participants 62 participants 79 participants
173 52 66
Responders at Month 36 Number Analyzed 198 participants 60 participants 85 participants
169 46 72
62.Secondary Outcome
Title Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36
Hide Description CGI-S scale was a 7-point scale used to assess severity of illness on a range of 1 to 7; where, 1= normal, not mentally ill, 2= borderline mentally ill, 3= mildly mentally ill, 4= moderately mentally ill, 5= markedly mentally ill, 6= severely mentally ill, and 7= among the most extremely mentally. Higher score indicated worse condition.
Time Frame Baseline, Month 3, 6, 12, 18, 24, 30 and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all participants in the database who had informed consent. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.
Arm/Group Title Sertraline Other Antidepressants Psychotherapy
Hide Arm/Group Description:
At baseline, participants in this group were those at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. At a visit post baseline, participants in this group were on sertraline only or sertraline and any other treatment since the previous visit.
At baseline, use of other antidepressants at baseline was a study exclusion criterion. However, a few participants were enrolled and initiated treatment with an antidepressant other than sertraline, and hence included in this group. At a visit post baseline, participants in this group were on another antidepressant only or on another antidepressant and psychotherapy since the previous visit.
At baseline, participants in this group were on psychotherapy only and were those who 1) were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. At a visit post baseline, participants in this group were those on psychotherapy only or no treatment at all since the previous visit.
Overall Number of Participants Analyzed 692 74 243
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 692 participants 3 participants 243 participants
Normal, Not Mentally ill
21
   3.0%
0
   0.0%
29
  11.9%
Borderline Mentally ill
28
   4.0%
0
   0.0%
17
   7.0%
Mildly Mentally ill
138
  19.9%
0
   0.0%
57
  23.5%
Moderately Mentally ill
377
  54.5%
3
 100.0%
107
  44.0%
Markedly Mentally ill
116
  16.8%
0
   0.0%
31
  12.8%
Severely Mentally ill
12
   1.7%
0
   0.0%
2
   0.8%
Among the Most Extremely Mentally ill
0
   0.0%
0
   0.0%
0
   0.0%
Month 3 Number Analyzed 556 participants 3 participants 178 participants
Normal, Not Mentally ill
32
   5.8%
0
   0.0%
18
  10.1%
Borderline Mentally ill
87
  15.6%
0
   0.0%
19
  10.7%
Mildly Mentally ill
163
  29.3%
1
  33.3%
60
  33.7%
Moderately Mentally ill
216
  38.8%
0
   0.0%
54
  30.3%
Markedly Mentally ill
55
   9.9%
1
  33.3%
23
  12.9%
Severely Mentally ill
3
   0.5%
1
  33.3%
4
   2.2%
Among the Most Extremely Mentally ill
0
   0.0%
0
   0.0%
0
   0.0%
Month 6 Number Analyzed 479 participants 36 participants 172 participants
Normal, Not Mentally ill
44
   9.2%
1
   2.8%
28
  16.3%
Borderline Mentally ill
93
  19.4%
4
  11.1%
33
  19.2%
Mildly Mentally ill
139
  29.0%
9
  25.0%
51
  29.7%
Moderately Mentally ill
162
  33.8%
15
  41.7%
43
  25.0%
Markedly Mentally ill
31
   6.5%
6
  16.7%
14
   8.1%
Severely Mentally ill
10
   2.1%
1
   2.8%
3
   1.7%
Among the Most Extremely Mentally ill
0
   0.0%
0
   0.0%
0
   0.0%
Month 12 Number Analyzed 383 participants 59 participants 146 participants
Normal, Not Mentally ill
42
  11.0%
2
   3.4%
32
  21.9%
Borderline Mentally ill
80
  20.9%
6
  10.2%
31
  21.2%
Mildly Mentally ill
133
  34.7%
13
  22.0%
39
  26.7%
Moderately Mentally ill
100
  26.1%
26
  44.1%
29
  19.9%
Markedly Mentally ill
22
   5.7%
11
  18.6%
11
   7.5%
Severely Mentally ill
6
   1.6%
1
   1.7%
4
   2.7%
Among the Most Extremely Mentally ill
0
   0.0%
0
   0.0%
0
   0.0%
Month 18 Number Analyzed 304 participants 74 participants 149 participants
Normal, Not Mentally ill
35
  11.5%
1
   1.4%
26
  17.4%
Borderline Mentally ill
66
  21.7%
13
  17.6%
29
  19.5%
Mildly Mentally ill
106
  34.9%
19
  25.7%
53
  35.6%
Moderately Mentally ill
76
  25.0%
33
  44.6%
34
  22.8%
Markedly Mentally ill
16
   5.3%
5
   6.8%
7
   4.7%
Severely Mentally ill
5
   1.6%
3
   4.1%
0
   0.0%
Among the Most Extremely Mentally ill
0
   0.0%
0
   0.0%
0
   0.0%
Month 24 Number Analyzed 263 participants 71 participants 139 participants
Normal, Not Mentally ill
39
  14.8%
4
   5.6%
25
  18.0%
Borderline Mentally ill
61
  23.2%
10
  14.1%
29
  20.9%
Mildly Mentally ill
100
  38.0%
17
  23.9%
48
  34.5%
Moderately Mentally ill
48
  18.3%
35
  49.3%
31
  22.3%
Markedly Mentally ill
13
   4.9%
5
   7.0%
5
   3.6%
Severely Mentally ill
2
   0.8%
0
   0.0%
1
   0.7%
Among the Most Extremely Mentally ill
0
   0.0%
0
   0.0%
0
   0.0%
Month 30 Number Analyzed 218 participants 66 participants 148 participants
Normal, Not Mentally ill
30
  13.8%
5
   7.6%
33
  22.3%
Borderline Mentally ill
58
  26.6%
13
  19.7%
27
  18.2%
Mildly Mentally ill
78
  35.8%
25
  37.9%
55
  37.2%
Moderately Mentally ill
45
  20.6%
19
  28.8%
29
  19.6%
Markedly Mentally ill
6
   2.8%
3
   4.5%
4
   2.7%
Severely Mentally ill
1
   0.5%
1
   1.5%
0
   0.0%
Among the Most Extremely Mentally ill
0
   0.0%
0
   0.0%
0
   0.0%
Month 36 Number Analyzed 204 participants 64 participants