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A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

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: NCT01372150
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : November 20, 2015
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: desvenlafaxine succinate sustained release
Drug: fluoxetine
Drug: placebo
Enrollment 340
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Fluoxetine Desvenlafaxine Succinate Sustained Release (DVS SR)
Hide Arm/Group Description Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase). Fluoxetine capsules 10 (milligram) mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily as appropriate for 1 week (taper/transition phase). DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
Period Title: Overall Study
Started 112 113 115
Treated 112 112 115
Completed 99 99 99
Not Completed 13 14 16
Reason Not Completed
Lack of Efficacy             3             0             1
Lost to Follow-up             4             5             6
Protocol Violation             1             0             3
Withdrawal by Subject             2             7             2
Other             1             0             2
Adverse Event             2             1             2
Randomized but not treated             0             1             0
Arm/Group Title Placebo Fluoxetine DVS SR Total
Hide Arm/Group Description Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase). Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase). DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week. Total of all reporting groups
Overall Number of Baseline Participants 112 112 115 339
Hide Baseline Analysis Population Description
Safety population - included all randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 112 participants 115 participants 339 participants
12.6  (2.89) 12.6  (2.89) 12.9  (3.12) 12.7  (2.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 112 participants 115 participants 339 participants
Female
64
  57.1%
57
  50.9%
63
  54.8%
184
  54.3%
Male
48
  42.9%
55
  49.1%
52
  45.2%
155
  45.7%
1.Primary Outcome
Title Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score
Hide Description Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) Population - included all randomized participants who received at least 1 dose of study drug, had a baseline primary efficacy assessment, and had at least one post-baseline primary efficacy assessment.
Arm/Group Title Placebo Fluoxetine DVS SR
Hide Arm/Group Description:
Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
Overall Number of Participants Analyzed 99 101 99
Mean (Standard Error)
Unit of Measure: Score on a Scale
-23.07  (1.18) -24.79  (1.17) -22.61  (1.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine
Comments Fluoxetine versus Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.226
Comments [Not Specified]
Method Mixed-effects model for repeated measure
Comments Mixed-effects model for repeated measures (MMRM)
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.71
Confidence Interval (2-Sided) 95%
-1.06 to 4.48
Estimation Comments Adjusted mean difference = placebo - fluoxetine
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments DVS SR versus Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.739
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-3.23 to 2.30
Estimation Comments Adjusted mean difference = Placebo - DVS SR
2.Secondary Outcome
Title Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score
Hide Description A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Fluoxetine DVS SR
Hide Arm/Group Description:
Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
Overall Number of Participants Analyzed 99 101 99
Mean (Standard Error)
Unit of Measure: Score on a Scale
-1.71  (0.12) -1.88  (0.12) -1.70  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine
Comments Fluoxetine versus Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.224
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.11 to 0.46
Estimation Comments Adjusted mean difference = Placebo - Fluoxetine
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments DVS SR versus Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.944
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.29 to 0.27
Estimation Comments Adjusted mean difference = Placebo - DVS SR
3.Secondary Outcome
Title Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Hide Description A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time Frame Baseline and Weeks 1, 2, 3, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Fluoxetine DVS SR
Hide Arm/Group Description:
Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
Overall Number of Participants Analyzed 105 105 111
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 1, Very Much Improved (n=102, 101, 111) 1.0 3.0 2.7
Week 1, Much Improved (n=102, 101, 111) 7.8 11.9 6.3
Week 1, Minimally Improved (n=102, 101, 111) 46.1 35.6 43.2
Week 1, No Change (n=102, 101, 111) 43.1 47.5 45.9
Week 1, Minimally Worse (n=102, 101, 111) 2.0 2.0 1.8
Week 1, Much Worse (n=102, 101, 111) 0 0 0
Week 1, Very Much Worse (n=102, 101, 111) 0 0 0
Week 2, Very Much Improved (n=103, 105, 110) 3.9 6.7 3.6
Week 2, Much Improved (n=103, 105, 110) 25.2 26.7 31.8
Week 2, Minimally Improved (n=103, 105, 110) 38.8 42.9 44.5
Week 2, No Change (n=103, 105, 110) 30.1 22.9 19.1
Week 2, Minimally Worse (n=103, 105, 110) 1.9 1.0 0.9
Week 2, Much Worse (n=103, 105, 110) 0 0 0
Week 2, Very Much Worse (n=103, 105, 110) 0 0 0
Week 3, Very Much Improved (n=105, 102, 107) 13.3 14.7 7.5
Week 3, Much Improved (n=105, 102, 107) 29.5 36.3 42.1
Week 3, Minimally Improved (n=105, 102, 107) 41.0 36.3 38.3
Week 3, No Change (n=105, 102, 107) 15.2 11.8 11.2
Week 3, Minimally Worse (n=105, 102, 107) 1.0 1.0 0.9
Week 3, Much Worse (n=105, 102, 107) 0 0 0
Week 3, Very Much Worse (n=105, 102, 107) 0 0 0
Week 4, Very Much Improved (n=101, 101, 100) 15.8 13.9 20.0
Week 4, Much Improved (n=101, 101, 100) 38.6 47.5 44.0
Week 4, Minimally Improved (n=101, 101, 100) 29.7 27.7 25.0
Week 4, No Change (n=101, 101, 100) 13.9 9.9 10.0
Week 4, Minimally Worse (n=101, 101, 100) 2.0 1.0 1.0
Week 4, Much Worse (n=101, 101, 100) 0 0 0
Week 4, Very Much Worse (n=101, 101, 100) 0 0 0
Week 6, Very Much Improved (n=100, 100, 102) 18.0 26.0 23.5
Week 6, Much Improved (n=100, 100, 102) 41.0 45.0 45.1
Week 6, Minimally Improved (n=100, 100, 102) 34.0 24.0 20.6
Week 6, No Change (n=100, 100, 102) 6.0 5.0 9.8
Week 6, Minimally Worse (n=100, 100, 102) 0 0 1
Week 6, Much Worse (n=100, 100, 102) 1.0 0 0
Week 6, Very Much Worse (n=100, 100, 102) 0 0 0
Week 8, Very Much Improved (n=99, 101, 99) 27.3 30.7 23.2
Week 8, Much Improved (n=99, 101, 99) 35.4 47.5 45.5
Week 8, Minimally Improved (n=99, 101, 99) 32.3 16.8 21.2
Week 8, No Change (n=99, 101, 99) 4.0 4.0 9.1
Week 8, Minimally Worse (n=99, 101, 99) 1.0 1.0 1.0
Week 8, Much Worse (n=99, 101, 99) 0 0 0
Week 8, Very Much Worse (n=99, 101, 99) 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine
Comments Fluoxetine versus Placebo - Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.924
Comments P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments DVS SR versus Placebo - Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.698
Comments P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine
Comments Fluoxetine versus Placebo - Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.214
Comments P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments DVS SR versus Placebo - Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine
Comments Fluoxetine versus Placebo - Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.314
Comments P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments DVS SR versus Placebo - Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.659
Comments P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine
Comments Fluoxetine versus Placebo - Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.577
Comments P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments DVS SR versus Placebo - Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.187
Comments P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine
Comments Fluoxetine versus Placebo - Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments DVS SR versus Placebo - Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.266
Comments P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine
Comments Fluoxetine versus Placebo - Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments DVS SR versus Placebo - Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.852
Comments P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of "Row Mean Scores Differences".
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
Hide Description A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time Frame Weeks 1, 2, 3, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Fluoxetine DVS SR
Hide Arm/Group Description:
Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
Overall Number of Participants Analyzed 105 105 111
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 1 (n=102, 101, 111) 8.82 14.85 9.01
Week 2 (n=103, 105, 110) 29.13 33.33 35.45
Week 3 (n=105, 102, 107) 42.86 50.98 49.53
Week 4 (n=101, 101, 100) 54.46 61.39 64.00
Week 6 (n=100, 100, 102) 59.00 71.00 68.63
Week 8 (n=99, 101, 99) 62.63 78.22 68.69
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine
Comments Fluoxetine versus Placebo - Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.186
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.550
Confidence Interval (2-Sided) 95%
0.226 to 1.335
Estimation Comments Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments DVS SR versus Placebo - Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.984
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.990
Confidence Interval (2-Sided) 95%
0.382 to 2.567
Estimation Comments Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine
Comments Fluoxetine versus Placebo - Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.462
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.795
Confidence Interval (2-Sided) 95%
0.431 to 1.465
Estimation Comments Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments DVS SR versus Placebo - Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.297
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.726
Confidence Interval (2-Sided) 95%
0.399 to 1.324
Estimation Comments Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine
Comments Fluoxetine versus Placebo - Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.194
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.688
Confidence Interval (2-Sided) 95%
0.391 to 1.210
Estimation Comments Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments DVS SR versus Placebo - Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.272
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.732
Confidence Interval (2-Sided) 95%
0.419 to 1.277
Estimation Comments Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine
Comments Flouxetine versus Placebo - Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.313
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.748
Confidence Interval (2-Sided) 95%
0.426 to 1.314
Estimation Comments Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments DVS SR versus Placebo - Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.157
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.663
Confidence Interval (2-Sided) 95%
0.376 to 1.171
Estimation Comments Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine
Comments Flouxetine versus Placebo - Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.579
Confidence Interval (2-Sided) 95%
0.319 to 1.050
Estimation Comments Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments DVS SR versus Placebo - Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.135
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.640
Confidence Interval (2-Sided) 95%
0.356 to 1.149
Estimation Comments Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine
Comments Flouxetine versus Placebo - Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.465
Confidence Interval (2-Sided) 95%
0.249 to 0.871
Estimation Comments Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR
Comments DVS SR versus Placebo - Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.343
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.751
Confidence Interval (2-Sided) 95%
0.415 to 1.357
Estimation Comments Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.
Time Frame Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
Adverse Event Reporting Description The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title Placebo Fluoxetine DVS SR
Hide Arm/Group Description Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase). Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase). DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
All-Cause Mortality
Placebo Fluoxetine DVS SR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Fluoxetine DVS SR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/112 (0.00%)   2/112 (1.79%)   2/115 (1.74%) 
Psychiatric disorders       
Disinhibition * 1  0/112 (0.00%)  0/112 (0.00%)  1/115 (0.87%) 
Suicidal ideation * 1  0/112 (0.00%)  1/112 (0.89%)  1/115 (0.87%) 
Suicide attempt * 1  0/112 (0.00%)  1/112 (0.89%)  0/115 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Fluoxetine DVS SR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/112 (39.29%)   39/112 (34.82%)   47/115 (40.87%) 
Gastrointestinal disorders       
Abdominal pain upper * 1  7/112 (6.25%)  9/112 (8.04%)  15/115 (13.04%) 
Nausea * 1  10/112 (8.93%)  13/112 (11.61%)  8/115 (6.96%) 
Vomiting * 1  4/112 (3.57%)  7/112 (6.25%)  5/115 (4.35%) 
General disorders       
Fatigue * 1  2/112 (1.79%)  6/112 (5.36%)  2/115 (1.74%) 
Infections and infestations       
Influenza * 1  0/112 (0.00%)  2/112 (1.79%)  6/115 (5.22%) 
Nasopharyngitis * 1  8/112 (7.14%)  7/112 (6.25%)  6/115 (5.22%) 
Upper respiratory tract infection * 1  6/112 (5.36%)  4/112 (3.57%)  6/115 (5.22%) 
Nervous system disorders       
Dizziness * 1  6/112 (5.36%)  3/112 (2.68%)  7/115 (6.09%) 
Headache * 1  21/112 (18.75%)  16/112 (14.29%)  19/115 (16.52%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01372150     History of Changes
Other Study ID Numbers: B2061014
3151A6-3356 ( Other Identifier: Alias Study Number )
2008-002063-13 ( EudraCT Number )
First Submitted: June 9, 2011
First Posted: June 13, 2011
Results First Submitted: October 19, 2015
Results First Posted: November 20, 2015
Last Update Posted: January 15, 2019