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Trial record 100 of 1309 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND weeks

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: NCT01371734
Recruitment Status : Completed
First Posted : June 13, 2011
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
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: Placebo
Enrollment 363
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo DVS SR Low Dose DVS SR High Dose
Hide Arm/Group Description Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study. DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study. DVS SR tablets 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
Period Title: Overall Study
Started 120 122 121
Completed 97 103 104
Not Completed 23 19 17
Reason Not Completed
Not specified             2             1             2
Withdrawal by Subject             3             4             9
Lost to Follow-up             5             3             1
Protocol Violation             3             1             2
Adverse Event             8             8             3
Lack of Efficacy             2             2             0
Arm/Group Title Placebo DVS SR Low Dose DVS SR High Dose Total
Hide Arm/Group Description Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study. DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study. DVS SR tablets 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study. Total of all reporting groups
Overall Number of Baseline Participants 120 122 121 363
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 120 participants 122 participants 121 participants 363 participants
13.2  (2.68) 13.1  (2.80) 12.9  (3.01) 13.0  (2.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 122 participants 121 participants 363 participants
Female
60
  50.0%
69
  56.6%
76
  62.8%
205
  56.5%
Male
60
  50.0%
53
  43.4%
45
  37.2%
158
  43.5%
1.Primary Outcome
Title Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)
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. Mean change from baseline was adjusted for the baseline total score, age group and gender.
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.

n is the number of participants with evaluable data.

Arm/Group Title Placebo DVS SR Low Dose DVS SR High Dose
Hide Arm/Group Description:
Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
DVS SR tablets 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
Overall Number of Participants Analyzed 119 120 121
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-22.85  (1.13) -23.70  (1.12) -24.37  (1.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR Low Dose
Comments Adjusted mean difference = Placebo - DVS SR Low Dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.587
Comments [Not Specified]
Method Mixed-effects model for repeated measure
Comments Hochberg procedure was used to control for multiplicity
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
-2.23 to 3.94
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR High Dose
Comments Adjusted mean difference = Placebo - DVS SR High Dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.333
Comments [Not Specified]
Method Mixed-effects model for repeated measure
Comments Hochberg procedure was used to control for multiplicity
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.52
Confidence Interval (2-Sided) 95%
-1.56 to 4.61
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)
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. Mean change from baseline was adjusted for the baseline total score, age group and gender.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population n is the number of participants with evaluable data.
Arm/Group Title Placebo DVS SR Low Dose DVS SR High Dose
Hide Arm/Group Description:
Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
DVS SR tablets 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
Overall Number of Participants Analyzed 119 120 121
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-1.49  (0.11) -1.51  (0.11) -1.65  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR Low Dose
Comments Adjusted mean difference = Placebo - DVS SR Low Dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.923
Comments [Not Specified]
Method Mixed-effects model for repeated measure
Comments Hochberg procedure was used to control for multiplicity
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.015
Confidence Interval (2-Sided) 95%
-0.29 to 0.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR High Dose
Comments Adjusted mean difference = Placebo - DVS SR High Dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.302
Comments [Not Specified]
Method Mixed-effects model for repeated measure
Comments Hochberg procedure was used to control for multiplicity
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.161
Confidence Interval (2-Sided) 95%
-0.14 to 0.47
Estimation Comments [Not Specified]
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 equals (=) more affected.
Time Frame Weeks 1, 2, 3, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population n is the number of participants with non-missing values
Arm/Group Title Placebo DVS SR Low Dose DVS SR High Dose
Hide Arm/Group Description:
Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
DVS SR tablets 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
Overall Number of Participants Analyzed 119 120 121
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 1, Very Much Improved (n=113, 112,115) 2.7 0.9 2.6
Week 1, Much Improved (n=113, 112, 115) 6.2 9.8 12.2
Week 1, Minimally Improved (n=113, 112, 115) 38.9 37.5 33.9
Week 1, No Change (n=113, 112, 115) 49.6 51.8 46.1
Week 1, Minimally Worse (n=113, 112, 115) 2.7 0 5.2
Week 1, Much Worse (n=113, 112, 115) 0 0 0
Week 1, Very Much Worse (n=113, 112, 115) 0 0 0
Week 2, Very Much Improved (n=114, 115, 109) 4.4 6.1 10.1
Week 2, Much Improved (n=114, 115, 109) 26.3 26.1 23.9
Week 2, Minimally Improved (n=114, 115, 109) 36.8 38.3 35.8
Week 2, No Change (n=114, 115, 109) 31.6 25.2 29.4
Week 2, Minimally Worse (n=114, 115, 109) 0 4.3 0
Week 2, Much Worse (n=114, 115, 109) 0.9 0 0.9
Week 2, Very Much Worse (n=114, 115, 109) 0 0 0
Week 3, Very Much Improved (n=108, 110, 110) 10.2 10.9 18.2
Week 3, Much Improved (n=108, 110, 110) 20.4 26.4 24.5
Week 3, Minimally Improved (n=108, 110, 110) 47.2 44.5 35.5
Week 3, No Change (n=108, 110, 110) 20.4 15.5 21.8
Week 3, Minimally Worse (n=108, 110, 110) 1.9 1.8 0
Week 3, Much Worse (n=108, 110, 110) 0 0 0
Week 3, Very Much Worse (n=108, 110, 110) 0 0.9 0
Week 4, Very Much Improved (n=104,108,113) 14.4 17.6 15.0
Week 4, Much Improved (n=104,108,113) 30.8 36.1 31.0
Week 4, Minimally Improved (n=104,108,113) 35.6 30.6 35.4
Week 4, No Change (n=104,108,113) 19.2 14.8 17.7
Week 4, Minimally Worse (n=104,108,113) 0 0.9 0.9
Week 4, Much Worse (n=104,108,113) 0 0 0
Week 4, Very Much Worse (n=104,108,113) 0 0 0
Week 6, Very Much Improved (n=106,104,104) 19.8 20.2 26.9
Week 6, Much Improved (n=106,104,104) 29.2 36.5 24.0
Week 6, Minimally Improved (n=106,104,104) 31.1 24.0 31.7
Week 6, No Change (n=106,104,104) 16.0 14.4 14.4
Week 6, Minimally Worse (n=106,104,104) 2.8 2.9 1.9
Week 6, Much Worse (n=106,104,104) 0 1.9 1.0
Week 6, Very Much Worse (n=106,104,104) 0.9 0 0
Week 8, Very Much Improved (n=102,105,106) 21.6 19.0 25.5
Week 8, Much Improved (n=102,105,106) 34.3 37.1 36.8
Week 8, Minimally Improved (n=102,105,106) 28.4 24.8 21.7
Week 8, No Change (n=102,105,106) 15.7 18.1 15.1
Week 8, Minimally Worse (n=102,105,106) 0 1.0 0.9
Week 8, Much Worse (n=102,105,106) 0 0 0
Week 8, Very Much Worse (n=102,105,106) 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR Low Dose
Comments Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.729
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR High Dose
Comments Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.756
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR Low Dose
Comments Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.765
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR High Dose
Comments Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.475
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR Low Dose
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.310
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR High Dose
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR Low Dose
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.254
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR High Dose
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.887
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR Low Dose
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.475
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR High Dose
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.407
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR Low Dose
Comments Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.696
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR High Dose
Comments Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.462
Comments [Not Specified]
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) or 2 (much 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 n is the number of participants with non-missing values
Arm/Group Title Placebo DVS SR Low Dose DVS SR High Dose
Hide Arm/Group Description:
Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
DVS SR tablets 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
Overall Number of Participants Analyzed 119 120 121
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 1 (n=113, 112, 115) 8.85 10.71 14.78
Week 2 (n=114, 115, 109) 30.70 32.17 33.94
Week 3 (n=108, 110, 110) 30.56 37.27 42.73
Week 4 (n=104, 108, 113) 45.19 53.70 46.02
Week 6 (n=106, 104, 104) 49.06 56.73 50.96
Week 8 (n=102, 105, 106) 55.88 56.19 62.26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR Low Dose
Comments Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.633
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.806
Confidence Interval (2-Sided) 95%
0.333 to 1.951
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR High Dose
Comments Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.172
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.561
Confidence Interval (2-Sided) 95%
0.245 to 1.285
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR Low Dose
Comments Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.826
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.939
Confidence Interval (2-Sided) 95%
0.536 to 1.644
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR High Dose
Comments Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.599
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.860
Confidence Interval (2-Sided) 95%
0.489 to 1.511
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR Low Dose
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.248
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.713
Confidence Interval (2-Sided) 95%
0.402 to 1.265
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR High Dose
Comments Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.564
Confidence Interval (2-Sided) 95%
0.320 to 0.995
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR Low Dose
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.210
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.708
Confidence Interval (2-Sided) 95%
0.412 to 1.216
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR High Dose
Comments Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.893
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.964
Confidence Interval (2-Sided) 95%
0.564 to 1.646
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR Low Dose
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.228
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.714
Confidence Interval (2-Sided) 95%
0.413 to 1.235
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR High Dose
Comments Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.751
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.916
Confidence Interval (2-Sided) 95%
0.531 to 1.579
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR Low Dose
Comments Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.925
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.974
Confidence Interval (2-Sided) 95%
0.561 to 1.689
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR High Dose
Comments Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.342
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.764
Confidence Interval (2-Sided) 95%
0.438 to 1.331
Estimation Comments [Not Specified]
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 8 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 DVS SR Low Dose DVS SR High Dose
Hide Arm/Group Description Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study. DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study. DVS SR tablets 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) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
All-Cause Mortality
Placebo DVS SR Low Dose DVS SR High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo DVS SR Low Dose DVS SR High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/120 (1.67%)   2/122 (1.64%)   1/121 (0.83%) 
Infections and infestations       
Abscess  1  0/120 (0.00%)  0/122 (0.00%)  1/121 (0.83%) 
Appendicitis  1  0/120 (0.00%)  0/122 (0.00%)  1/121 (0.83%) 
Psychiatric disorders       
Aggression  1  0/120 (0.00%)  1/122 (0.82%)  0/121 (0.00%) 
Suicide attempt  1  1/120 (0.83%)  1/122 (0.82%)  0/121 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatomyositis  1  1/120 (0.83%)  0/122 (0.00%)  0/121 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo DVS SR Low Dose DVS SR High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/120 (28.33%)   46/122 (37.70%)   53/121 (43.80%) 
Gastrointestinal disorders       
Abdominal pain upper  1  9/120 (7.50%)  7/122 (5.74%)  11/121 (9.09%) 
Nausea  1  7/120 (5.83%)  12/122 (9.84%)  14/121 (11.57%) 
Vomiting  1  4/120 (3.33%)  1/122 (0.82%)  9/121 (7.44%) 
General disorders       
Fatigue  1  2/120 (1.67%)  4/122 (3.28%)  9/121 (7.44%) 
Infections and infestations       
Nasopharyngitis  1  2/120 (1.67%)  8/122 (6.56%)  7/121 (5.79%) 
Nervous system disorders       
Headache  1  15/120 (12.50%)  22/122 (18.03%)  25/121 (20.66%) 
Psychiatric disorders       
Insomnia  1  1/120 (0.83%)  7/122 (5.74%)  4/121 (3.31%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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: NCT01371734     History of Changes
Other Study ID Numbers: B2061032
3151A6-3343 ( Other Identifier: Alias Study Number )
2008-001875-32 ( EudraCT Number )
First Submitted: June 9, 2011
First Posted: June 13, 2011
Results First Submitted: March 7, 2016
Results First Posted: March 20, 2017
Last Update Posted: March 20, 2017