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Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT01432457
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : January 20, 2014
Last Update Posted : January 20, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: desvenlafaxine succinate sustained-release 50 mg/day
Drug: desvenlafaxine succinate sustained-release 100 mg/day
Drug: placebo
Enrollment 924

Recruitment Details Subjects were recruited in the United States from October 2011 to May 2012.
Pre-assignment Details Subjects were screened up to 2 weeks.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg
Hide Arm/Group Description Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper. Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper. Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
Period Title: Overall Study
Started 306 306 312
Completed 269 258 253
Not Completed 37 48 59
Reason Not Completed
Adverse Event             7             10             16
Lack of Efficacy             2             1             1
Lost to Follow-up             11             15             20
Protocol Violation             3             2             6
Withdrawal by Subject             6             11             9
Reasons not defined             2             3             4
Did not take study drug             6             6             3
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg Total
Hide Arm/Group Description Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper. Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper. Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper. Total of all reporting groups
Overall Number of Baseline Participants 300 300 309 909
Hide Baseline Analysis Population Description
The numbers are correct. Participants flow starts with all randomized subjects while baseline is summarized for safety population defined as randomized AND took at least one dose. Started- (Other Did not take study drug) is the number for baseline summary.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 300 participants 300 participants 309 participants 909 participants
41.72  (12.42) 41.78  (13.56) 41.30  (12.80) 41.60  (12.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants 300 participants 309 participants 909 participants
Female
173
  57.7%
172
  57.3%
165
  53.4%
510
  56.1%
Male
127
  42.3%
128
  42.7%
144
  46.6%
399
  43.9%
1.Primary Outcome
Title Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
Time Frame Baseline to Week 8 (final on-therapy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline HAM-D17 score as a covariate.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg
Hide Arm/Group Description:
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
Overall Number of Participants Analyzed 267 257 252
Mean (Standard Error)
Unit of Measure: Units on a scale
-9.71  (0.42) -11.28  (0.42) -11.67  (0.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.57
Confidence Interval (2-Sided) 95%
0.44 to 2.69
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.96
Confidence Interval (2-Sided) 95%
0.84 to 3.08
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8
Time Frame Baseline to Week 8 (final on-therapy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg
Hide Arm/Group Description:
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
Overall Number of Participants Analyzed 294 291 301
Mean (Standard Error)
Unit of Measure: Units on a scale
-9.50  (0.44) -10.86  (0.43) -11.16  (0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.28 to 2.45
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 1.67
Confidence Interval (2-Sided) 95%
0.59 to 2.74
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)
Hide Description CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.
Time Frame Baseline to Week 8 (final on-therapy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: The Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores based on last-observation-carried-forward (LOCF) data.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg
Hide Arm/Group Description:
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
Overall Number of Participants Analyzed 294 291 301
Measure Type: Number
Unit of Measure: number of participants
1=Very much improved 55 57 81
2=Much improved 76 104 98
3=Minimally improved 83 79 69
4=No change 73 48 49
5=Minimally worse 7 3 4
6=Much worse 0 0 0
7=Very much worse 0 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of "Row Mean Scores Differences" controlling for site.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of "Row Mean Scores Differences" controlling for site.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)
Hide Description CGI-S: 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 = worse state.
Time Frame Baseline to Week 8 (final on-therapy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline CGI-S score as a covariate.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg
Hide Arm/Group Description:
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
Overall Number of Participants Analyzed 265 257 252
Mean (Standard Error)
Unit of Measure: Units on scale
-1.27  (0.06) -1.47  (0.06) -1.55  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
0.05 to 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
0.13 to 0.43
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score
Hide Description CGI-S: 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 = worse state.
Time Frame Baseline to Week 8 (final on-therapy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg
Hide Arm/Group Description:
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
Overall Number of Participants Analyzed 294 291 301
Mean (Standard Error)
Unit of Measure: Units on scale
-1.21  (0.07) -1.38  (0.07) -1.43  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.01 to 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
0.04 to 0.39
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate
Time Frame Baseline to Week 8 (final on-therapy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last-observation-carried-forward (LOCF) data was used.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg
Hide Arm/Group Description:
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
Overall Number of Participants Analyzed 294 291 301
Measure Type: Number
Unit of Measure: percentage of the number of participants
39.46 45.02 47.51
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.198
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.242
Confidence Interval (2-Sided) 95%
0.893 to 1.726
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.378
Confidence Interval (2-Sided) 95%
0.995 to 1.910
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate
Time Frame Baseline to week 8 (final on-therapy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last- observation-carried-forward (LOCF) data was used.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg
Hide Arm/Group Description:
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
Overall Number of Participants Analyzed 294 291 301
Measure Type: Number
Unit of Measure: percentage of the number of participants
21.77 24.05 28.57
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.615
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.105
Confidence Interval (2-Sided) 95%
0.749 to 1.631
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
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 Adjusted Odds Ratio
Estimated Value 1.412
Confidence Interval (2-Sided) 95%
0.969 to 2.057
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score
Hide Description

The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated.

Each individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function.

Time Frame Baseline to Week 8 (final on-therapy)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population: randomized subjects who have taken at least 1 dose of double-blind investigational product. Imputation technique: ASEX scale total score analyzed using analysis of covariance based on LOCF data. ASEX data only analyzed for subjects indicating sexual activity at baseline and a timepoint during post-baseline.
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg
Hide Arm/Group Description:
Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
Overall Number of Participants Analyzed 135 138 149
Mean (Standard Error)
Unit of Measure: Units on a scale
-0.45  (0.36) -0.35  (0.35) -0.13  (0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.837
Comments p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.98 to 0.80
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 100 mg
Comments The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.471
Comments p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-1.19 to 0.55
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Placebo DVS SR 50 mg DVS SR 100 mg
Hide Arm/Group Description Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper. Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper. Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
All-Cause Mortality
Placebo DVS SR 50 mg DVS SR 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo DVS SR 50 mg DVS SR 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/300 (2.00%)   2/300 (0.67%)   2/309 (0.65%) 
Blood and lymphatic system disorders       
Lymphadenopathy  1  1/300 (0.33%)  0/300 (0.00%)  0/309 (0.00%) 
Cardiac disorders       
Atrial fibrillation  2  0/300 (0.00%)  0/300 (0.00%)  1/309 (0.32%) 
Gastrointestinal disorders       
Constipation  3  1/300 (0.33%)  0/300 (0.00%)  0/309 (0.00%) 
General disorders       
Hyperthermia  4  0/300 (0.00%)  1/300 (0.33%)  0/309 (0.00%) 
Injury, poisoning and procedural complications       
Intentional overdose  5  0/300 (0.00%)  1/300 (0.33%)  0/309 (0.00%) 
Lower limb fracture  6  1/300 (0.33%)  0/300 (0.00%)  0/309 (0.00%) 
Investigations       
Electrocardiogram abnormal  7  1/300 (0.33%)  0/300 (0.00%)  0/309 (0.00%) 
Serum serotonin increased  8 [1]  0/300 (0.00%)  1/300 (0.33%)  0/309 (0.00%) 
Nervous system disorders       
Motor dysfunction  9  0/300 (0.00%)  1/300 (0.33%)  0/309 (0.00%) 
Psychiatric disorders       
Abnormal behaviour  10 [2]  1/300 (0.33%)  0/300 (0.00%)  0/309 (0.00%) 
Depressive symptom  11 [3]  1/300 (0.33%)  0/300 (0.00%)  0/309 (0.00%) 
Suicidal ideation  12  0/300 (0.00%)  1/300 (0.33%)  1/309 (0.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, Lymphadenopathy
2
Term from vocabulary, Atrial fibrillation
3
Term from vocabulary, Constipation
4
Term from vocabulary, Hyperthermia
5
Term from vocabulary, Intentional overdose
6
Term from vocabulary, Lower limb fracture
7
Term from vocabulary, Abnormal ECG
8
Term from vocabulary, Significantly elevat
9
Term from vocabulary, Impaired motor
10
Term from vocabulary, Abnormal behavior
11
Term from vocabulary, Increased depressive
12
Term from vocabulary, Suicidal ideation
[1]
Significantly elevated serotonin level
[2]
Abnormal behavior as a result of reaction to alcohol and unknown substance
[3]
Increased depressive symptoms
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 50 mg DVS SR 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   110/300 (36.67%)   159/300 (53.00%)   163/309 (52.75%) 
Gastrointestinal disorders       
Constipation  1  11/300 (3.67%)  17/300 (5.67%)  12/309 (3.88%) 
Diarrhoea  2  18/300 (6.00%)  26/300 (8.67%)  19/309 (6.15%) 
Dry mouth  3  24/300 (8.00%)  31/300 (10.33%)  37/309 (11.97%) 
Nausea  4  24/300 (8.00%)  48/300 (16.00%)  52/309 (16.83%) 
General disorders       
Fatigue  5  7/300 (2.33%)  10/300 (3.33%)  17/309 (5.50%) 
Metabolism and nutrition disorders       
Decreased appetite  6  5/300 (1.67%)  12/300 (4.00%)  18/309 (5.83%) 
Nervous system disorders       
Dizziness  7  14/300 (4.67%)  28/300 (9.33%)  32/309 (10.36%) 
Headache  8  32/300 (10.67%)  57/300 (19.00%)  61/309 (19.74%) 
Somnolence  9  12/300 (4.00%)  17/300 (5.67%)  16/309 (5.18%) 
Psychiatric disorders       
Insomnia  10  11/300 (3.67%)  20/300 (6.67%)  25/309 (8.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, Constipation
2
Term from vocabulary, Diarrhoea
3
Term from vocabulary, Dry mouth
4
Term from vocabulary, Nausea
5
Term from vocabulary, Fatigue
6
Term from vocabulary, Decreased appetite
7
Term from vocabulary, Dizziness
8
Term from vocabulary, Headache
9
Term from vocabulary, Daytime drowsiness
10
Term from vocabulary, Insomnia
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01432457     History of Changes
Other Study ID Numbers: B2061028
3151A1-4420
First Submitted: September 9, 2011
First Posted: September 13, 2011
Results First Submitted: June 27, 2013
Results First Posted: January 20, 2014
Last Update Posted: January 20, 2014