Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women

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: NCT00369343
Recruitment Status : Completed
First Posted : August 29, 2006
Results First Posted : May 7, 2012
Last Update Posted : May 7, 2012
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Depression
Depressive Disorder
Depressive Disorder, Major
Interventions Drug: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)
Drug: Placebo
Enrollment 381
Recruitment Details Patients were recruited in the United States from September 2006 to September 2007.
Pre-assignment Details Patients were screened over 4 weeks.
Arm/Group Title Desvenlafaxine Succinate Sustained-Release (DVS SR) Placebo
Hide Arm/Group Description Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days. Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Period Title: Double-blind Phase
Started 256 125
Completed 212 109
Not Completed 44 16
Reason Not Completed
Adverse Event             19             4
Failed to return             2             0
Lost to Follow-up             9             2
Protocol Violation             2             0
Withdrawal by Subject             8             6
Lack of Efficacy             0             4
Protocol deviation             4             0
Period Title: Open-label Phase
Started 212 109
Completed 155 79
Not Completed 57 30
Reason Not Completed
Adverse Event             19             7
Failed to return             4             0
Physician Decision             2             0
Lost to Follow-up             5             3
inadvertently reported study completers             3             2
Protocol Violation             1             3
Withdrawal by Subject             15             6
Lack of Efficacy             4             3
Lack of continuance tolerability             3             4
did not take study drug             1             2
Arm/Group Title Desvenlafaxine Succinate Sustained-Release (DVS SR) Placebo Total
Hide Arm/Group Description Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days. Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days. Total of all reporting groups
Overall Number of Baseline Participants 256 125 381
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 256 participants 125 participants 381 participants
52.01  (6.50) 52.56  (7.17) 52.19  (6.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 256 participants 125 participants 381 participants
Female
256
 100.0%
125
 100.0%
381
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.
Hide Description HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, who took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Mixed model repeated measures (MMRM) modeling included all available observed data for each patient and no missing values were imputed.
Arm/Group Title Desvenlafaxine Succinate Sustained-Release (DVS SR) Placebo
Hide Arm/Group Description:
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Overall Number of Participants Analyzed 157 81
Mean (Standard Error)
Unit of Measure: units on scale
-12.64  (0.53) -8.33  (0.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-Release (DVS SR), Placebo
Comments [Not Specified]
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 Mixed Models Repeated Measures (MMRM) used baseline as a covariate and factors for center, week and treatment.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.32
Confidence Interval 95%
2.53 to 6.11
Estimation Comments DVS SR adjusted mean change minus placebo adjusted mean change.
2.Secondary Outcome
Title Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score
Hide Description CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient’s illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).
Arm/Group Title Desvenlafaxine Succinate Sustained-Release (DVS SR) Placebo
Hide Arm/Group Description:
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Overall Number of Participants Analyzed 186 97
Measure Type: Number
Unit of Measure: percentage of patients
1 (very much improved) 42.5 22.7
2 (much improved) 25.3 18.6
3 (minimally improved) 16.7 17.5
4 (no change) 13.4 32.0
5 (minimally worse) 1.1 7.2
6 (much worse) 0.5 2.1
7 (very much worse) 0.5 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-Release (DVS SR), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments DVS SR compared to Placebo for CGI-I scores of either 1 (very much improved) or 2 (much improved).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Patients Achieving Remission
Hide Description Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).
Arm/Group Title Desvenlafaxine Succinate Sustained-Release (DVS SR) Placebo
Hide Arm/Group Description:
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Overall Number of Participants Analyzed 186 98
Measure Type: Number
Unit of Measure: percentage of patients
38.2 22.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-Release (DVS SR), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments DVS SR compared with Placebo.
Method Chi-squared
Comments Logistic regression model with treatment and site as factors and baseline score as a covariate.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.132
Confidence Interval 95%
1.22 to 3.74
Estimation Comments Adjusted odds ratio of DVS SR to Placebo. Odds ratio adjusted for baseline, treatment and site.
4.Secondary Outcome
Title Percentage of Patients Achieving Response to Treatment
Hide Description A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).
Arm/Group Title Desvenlafaxine Succinate Sustained-Release (DVS SR) Placebo
Hide Arm/Group Description:
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Overall Number of Participants Analyzed 186 98
Measure Type: Number
Unit of Measure: percentage of patients
58.6 31.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-Release (DVS SR), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments DVS SR compared with Placebo.
Method Chi-squared
Comments Logistic regression model with treatment and site as factors and baseline score as a covariate.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.125
Confidence Interval 95%
1.85 to 5.27
Estimation Comments Adjusted odds ratio of DVS SR to Placebo. Odd ratio adjusted for baseline, treatment and site.
5.Secondary Outcome
Title Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8
Hide Description The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A score minus baseline adjusted mean score.
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Mixed model repeated measures (MMRM) modeling included all available observed data for each patient and no missing values were imputed.
Arm/Group Title Desvenlafaxine Succinate Sustained-Release (DVS SR) Placebo
Hide Arm/Group Description:
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Overall Number of Participants Analyzed 158 81
Mean (Standard Error)
Unit of Measure: units on scale
-8.62  (0.44) -5.89  (0.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-Release (DVS SR), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.74
Confidence Interval 95%
1.24 to 4.23
Estimation Comments Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score.
6.Secondary Outcome
Title Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8
Hide Description EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.
Time Frame Baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation.
Arm/Group Title Desvenlafaxine Succinate Sustained-Release (DVS SR) Placebo
Hide Arm/Group Description:
Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
Overall Number of Participants Analyzed 158 81
Mean (Standard Error)
Unit of Measure: units on scale
0.18  (0.02) 0.06  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-Release (DVS SR), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Mixed Model Repeated Measures (MMRM) with treatment and site as factors and baseline as covariate.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.12
Confidence Interval 95%
-0.18 to -0.06
Estimation Comments Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score.
7.Secondary Outcome
Title Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months
Hide Description HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50. Change= Final Evaluation mean HAM-D17 minus baseline mean HAM-D17.
Time Frame open label baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.
Arm/Group Title DVS SR / DVS SR Placebo / DVS SR
Hide Arm/Group Description:
Patients were in the DVS SR arm during both the double-blind and open-label phase.
Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
Overall Number of Participants Analyzed 207 103
Mean (Standard Deviation)
Unit of Measure: units on scale
-12.52  (7.17) -12.45  (6.85)
8.Secondary Outcome
Title Clinical Global Impression Improvement (CGI-I) Score
Hide Description CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale the clinician rates how much the patient’s illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase.
Arm/Group Title DVS SR / DVS SR Placebo / DVS SR
Hide Arm/Group Description:
Patients were in the DVS SR arm during both the double-blind and open-label phase.
Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
Overall Number of Participants Analyzed 208 103
Mean (Standard Deviation)
Unit of Measure: units on scale
1.55  (1.00) 1.56  (0.99)
9.Secondary Outcome
Title Percentage of Patients Achieving Remission
Hide Description Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.
Arm/Group Title DVS SR / DVS SR Placebo / DVS SR
Hide Arm/Group Description:
Patients were in the DVS SR arm during both the double-blind and open-label phase.
Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
Overall Number of Participants Analyzed 207 103
Measure Type: Number
Unit of Measure: percentage of patients
55.6 48.5
10.Secondary Outcome
Title Percentage of Patients Achieving a Response to Treatment
Hide Description A responder is defined as a patient with ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression - 17-item (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.
Arm/Group Title DVS SR / DVS SR Placebo / DVS SR
Hide Arm/Group Description:
Patients were in the DVS SR arm during both the double-blind and open-label phase.
Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
Overall Number of Participants Analyzed 207 103
Measure Type: Number
Unit of Measure: percentage of patients responding
70.5 66.0
11.Secondary Outcome
Title Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months
Hide Description The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= Final Evaluation mean HAM-A score minus baseline mean score.
Time Frame open label baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.
Arm/Group Title DVS SR / DVS SR Placebo / DVS SR
Hide Arm/Group Description:
Patients were in the DVS SR arm during both the double-blind and open-label phase.
Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
Overall Number of Participants Analyzed 207 103
Mean (Standard Deviation)
Unit of Measure: units on scale
-10.95  (6.90) -10.38  (5.64)
12.Secondary Outcome
Title Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months
Hide Description EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.
Time Frame open label baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.
Arm/Group Title DVS SR / DVS SR Placebo / DVS SR
Hide Arm/Group Description:
Patients were in the DVS SR arm during both the double-blind and open-label phase.
Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
Overall Number of Participants Analyzed 208 102
Mean (Standard Deviation)
Unit of Measure: units on scale
0.19  (0.26) 0.22  (0.31)
13.Secondary Outcome
Title Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
Hide Description DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of “new symptoms” and “old (but worse) symptoms” (1) and 0 for “old and unchanged symptom,” “absent,” or “old symptom but improved” for a total possible range of 0 to 43. A higher score indicates more symptoms.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label (OL) safety population: Patients completed double-blind and continued in OL with ≥1 dose study drug. Excluded patients lost to follow-up and discontinued with <4 wks therapy. Patients analyzed varied by time (0mg, 100mg, 200mg): Early Termination (n=9,98,207); Taper week 1 (n=4,76,193); Taper week 2 (n=5,75,195); Post-taper (n=5,71,192)
Arm/Group Title 0 mg 100 mg 200 mg
Hide Arm/Group Description:
Placebo
DVS SR 100mg dosage was reduced to DVS SR 50mg for 7 days.
DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
Overall Number of Participants Analyzed 9 98 207
Mean (Standard Deviation)
Unit of Measure: units on scale
End of 8 week DB / OL phase or early termination 4.00  (5.05) 2.07  (4.03) 1.27  (3.40)
Taper week 1 2.00  (2.16) 3.32  (4.35) 2.47  (3.61)
Taper week 2 1.40  (3.13) 5.29  (5.96) 3.76  (4.71)
Post-taper 0.60  (0.89) 1.41  (2.18) 2.46  (3.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0 mg, 100 mg
Comments 100mg vs. Placebo (0mg) post taper
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.553
Comments t-test adjusted by multiple comparison
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0 mg, 200 mg
Comments 200mg vs. Placebo (0mg) post taper
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments t-test adjusted by multiple comparison
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Double-blind DVS SR Double-blind Placebo Open-label DVS SR/ DVS SR Open-label Placebo/DVS SR
Hide Arm/Group Description

Days 1 to 7:

Patients will be instructed to take 1-50mg tablet per day

Days 8 to 14:

Patients will be instructed to take 1-100mg tablet per day

Days 15 to 56:

At the discretion of the investigator, patients may be assigned to 100mg or 200mg tablets per day

Placebo administered daily for 8 weeks Patients were in the DVS SR arm during both the double-blind and open-label phase. Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
All-Cause Mortality
Double-blind DVS SR Double-blind Placebo Open-label DVS SR/ DVS SR Open-label Placebo/DVS SR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Double-blind DVS SR Double-blind Placebo Open-label DVS SR/ DVS SR Open-label Placebo/DVS SR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3   2   12   2 
Blood and lymphatic system disorders         
Coagulation disorder *  0/256 (0.00%)  0/125 (0.00%)  1/208 (0.48%)  0/103 (0.00%) 
Cardiac disorders         
Hypertension *  1/256 (0.39%)  0/125 (0.00%)  0/208 (0.00%)  0/103 (0.00%) 
Cerebrovascular disorder *  0/256 (0.00%)  1/125 (0.80%)  0/208 (0.00%)  0/103 (0.00%) 
Supraventricular tachycardia *  0/256 (0.00%)  0/125 (0.00%)  1/208 (0.48%)  0/103 (0.00%) 
General disorders         
Infection *  1/256 (0.39%)  0/125 (0.00%)  0/208 (0.00%)  0/103 (0.00%) 
Medication error *  1/256 (0.39%)  0/125 (0.00%)  0/208 (0.00%)  0/103 (0.00%) 
Chest pain *  1/256 (0.39%)  0/125 (0.00%)  0/208 (0.00%)  1/103 (0.97%) 
Accidental overdose *  0/256 (0.00%)  0/125 (0.00%)  3/208 (1.44%)  0/103 (0.00%) 
Overdose *  0/256 (0.00%)  0/125 (0.00%)  2/208 (0.96%)  0/103 (0.00%) 
Allergic reaction *  0/256 (0.00%)  0/125 (0.00%)  1/208 (0.48%)  0/103 (0.00%) 
Nervous system disorders         
Psychotic depression *  1/256 (0.39%)  0/125 (0.00%)  0/208 (0.00%)  0/103 (0.00%) 
Psychosis *  0/256 (0.00%)  0/125 (0.00%)  1/208 (0.48%)  0/103 (0.00%) 
Reproductive system and breast disorders         
Uterine fibroids enlarged *  0/256 (0.00%)  0/125 (0.00%)  0/208 (0.00%)  1/103 (0.97%) 
Endometrial carcinoma *  0/256 (0.00%)  0/125 (0.00%)  1/208 (0.48%)  0/103 (0.00%) 
Breast carcinoma *  0/256 (0.00%)  0/125 (0.00%)  1/208 (0.48%)  0/103 (0.00%) 
Skin and subcutaneous tissue disorders         
Skin carcinoma *  0/256 (0.00%)  1/125 (0.80%)  0/208 (0.00%)  0/103 (0.00%) 
Skin melanoma *  0/256 (0.00%)  0/125 (0.00%)  1/208 (0.48%)  0/103 (0.00%) 
Vascular disorders         
Cerebral ischemia *  0/256 (0.00%)  0/125 (0.00%)  1/208 (0.48%)  0/103 (0.00%) 
Deep vein thrombosis *  0/256 (0.00%)  0/125 (0.00%)  1/208 (0.48%)  0/103 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Double-blind DVS SR Double-blind Placebo Open-label DVS SR/ DVS SR Open-label Placebo/DVS SR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   217   94   198   97 
Ear and labyrinth disorders         
Tinnitus *  0/256 (0.00%)  0/125 (0.00%)  15/208 (7.21%)  2/103 (1.94%) 
Eye disorders         
Abnormal vision *  0/256 (0.00%)  0/125 (0.00%)  13/208 (6.25%)  5/103 (4.85%) 
Gastrointestinal disorders         
Anorexia *  15/256 (5.86%)  1/125 (0.80%)  12/208 (5.77%)  6/103 (5.83%) 
Constipation *  36/256 (14.06%)  8/125 (6.40%)  37/208 (17.79%)  22/103 (21.36%) 
Diarrhea *  22/256 (8.59%)  13/125 (10.40%)  33/208 (15.87%)  15/103 (14.56%) 
Dry mouth *  61/256 (23.83%)  12/125 (9.60%)  56/208 (26.92%)  23/103 (22.33%) 
Dyspepsia *  16/256 (6.25%)  2/125 (1.60%)  20/208 (9.62%)  4/103 (3.88%) 
Nausea *  43/256 (16.80%)  15/125 (12.00%)  52/208 (25.00%)  32/103 (31.07%) 
Vomiting *  0/256 (0.00%)  0/125 (0.00%)  7/208 (3.37%)  9/103 (8.74%) 
General disorders         
Abdominal pain *  11/256 (4.30%)  8/125 (6.40%)  21/208 (10.10%)  8/103 (7.77%) 
Asthenia *  17/256 (6.64%)  10/125 (8.00%)  21/208 (10.10%)  11/103 (10.68%) 
Headache *  68/256 (26.56%)  26/125 (20.80%)  82/208 (39.42%)  43/103 (41.75%) 
Infection *  16/256 (6.25%)  10/125 (8.00%)  40/208 (19.23%)  18/103 (17.48%) 
Pain *  8/256 (3.13%)  7/125 (5.60%)  20/208 (9.62%)  12/103 (11.65%) 
Accidental injury *  0/256 (0.00%)  0/125 (0.00%)  35/208 (16.83%)  12/103 (11.65%) 
Back pain *  0/256 (0.00%)  0/125 (0.00%)  13/208 (6.25%)  6/103 (5.83%) 
Flu syndrome *  0/256 (0.00%)  0/125 (0.00%)  11/208 (5.29%)  5/103 (4.85%) 
Metabolism and nutrition disorders         
Weight gain *  0/256 (0.00%)  0/125 (0.00%)  17/208 (8.17%)  9/103 (8.74%) 
Musculoskeletal and connective tissue disorders         
Arthralgia *  0/256 (0.00%)  0/125 (0.00%)  18/208 (8.65%)  6/103 (5.83%) 
Nervous system disorders         
Dizziness *  29/256 (11.33%)  9/125 (7.20%)  6/208 (2.88%)  6/103 (5.83%) 
Insomnia *  29/256 (11.33%)  8/125 (6.40%)  32/208 (15.38%)  16/103 (15.53%) 
Nervousness *  13/256 (5.08%)  4/125 (3.20%)  14/208 (6.73%)  7/103 (6.80%) 
Somnolence *  37/256 (14.45%)  9/125 (7.20%)  27/208 (12.98%)  15/103 (14.56%) 
Abnormal dreams *  0/256 (0.00%)  0/125 (0.00%)  15/208 (7.21%)  1/103 (0.97%) 
Anxiety *  0/256 (0.00%)  0/125 (0.00%)  6/208 (2.88%)  6/103 (5.83%) 
Hostility *  0/256 (0.00%)  0/125 (0.00%)  3/208 (1.44%)  7/103 (6.80%) 
Respiratory, thoracic and mediastinal disorders         
Pharyngitis *  0/256 (0.00%)  0/125 (0.00%)  12/208 (5.77%)  10/103 (9.71%) 
Rhinitis *  0/256 (0.00%)  0/125 (0.00%)  14/208 (6.73%)  7/103 (6.80%) 
Sinusitis *  0/256 (0.00%)  0/125 (0.00%)  23/208 (11.06%)  11/103 (10.68%) 
Upper respiratory infection *  0/256 (0.00%)  0/125 (0.00%)  19/208 (9.13%)  9/103 (8.74%) 
Skin and subcutaneous tissue disorders         
Sweating *  17/256 (6.64%)  3/125 (2.40%)  20/208 (9.62%)  12/103 (11.65%) 
Vascular disorders         
Hypertension *  17/256 (6.64%)  2/125 (1.60%)  21/208 (10.10%)  4/103 (3.88%) 
Vasodilatation *  15/256 (5.86%)  5/125 (4.00%)  18/208 (8.65%)  7/103 (6.80%) 
*
Indicates events were collected by non-systematic assessment
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.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Name/Title: U. S. Contact Center
Organization: Wyeth
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00369343     History of Changes
Other Study ID Numbers: 3151A1-403
First Submitted: August 25, 2006
First Posted: August 29, 2006
Results First Submitted: November 26, 2008
Results First Posted: May 7, 2012
Last Update Posted: May 7, 2012