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Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00887224
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : June 27, 2012
Last Update Posted : November 21, 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
Drug: Desvenlafaxine succinate sustained release 25 mg
Drug: Placebo
Enrollment 874
Recruitment Details  
Pre-assignment Details 1072 participants were screened, 874 were enrolled into Desvenlafaxine succinate sustained release (DVS SR) open-label 8-week response phase; 659 entered into 12-week open label stability phase. After 20 weeks of open-label treatment 548 subjects were randomized to the 6-month double-blind phase to receive either placebo or to continue with DVS SR.
Arm/Group Title DVS SR 50 mg (Open-label Phase) Placebo (Double-blind Phase) DVS SR 50 mg (Double-blind Phase)
Hide Arm/Group Description Desvenlafaxine succinate sustained release (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population). Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population). DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population).
Period Title: Open-label Response (OLR) Phase
Started 874 0 0
Completed 752 0 0
Not Completed 122 0 0
Reason Not Completed
Adverse Event             46             0             0
Failed to return             6             0             0
Lack of Efficacy             26             0             0
Lost to Follow-up             16             0             0
Other             1             0             0
Protocol Violation             12             0             0
Withdrawal by Subject             15             0             0
Period Title: Between OLR and OLS Phases
Started 752 0 0
Completed 659 0 0
Not Completed 93 0 0
Period Title: Open-label Stability (OLS) Phase
Started 659 0 0
Completed 576 0 0
Not Completed 83 0 0
Reason Not Completed
Adverse Event             22             0             0
Failed to return             3             0             0
Lack of Efficacy             16             0             0
Lost to Follow-up             9             0             0
Other             1             0             0
Protocol Violation             13             0             0
Withdrawal by Subject             19             0             0
Period Title: Between OLS and DB Phases
Started 576 0 0
Completed 548 0 0
Not Completed 28 0 0
Period Title: OL Taper Phase / OL Follow Up
Started 307 [1] 0 0
Discontinued Open-label Taper 144 [2] 0 0
Completed 163 0 0
Not Completed 144 0 0
Reason Not Completed
Adverse Event             28             0             0
Failed to return             17             0             0
Physician Decision             10             0             0
Lost to Follow-up             8             0             0
Other             30             0             0
Protocol Violation             3             0             0
Withdrawal by Subject             48             0             0
[1]
Could have entered 7-day taper period at any time during either the OLR phase or OLS phase.
[2]
Could have discontinued at any time during OL taper phase or OL Follow-up (7 days after last dose).
Period Title: Double-blind (DB) Phase
Started 0 276 [1] 272
Completed 0 176 210
Not Completed 0 100 62
Reason Not Completed
Adverse Event             0             7             2
Failed to return             0             2             2
Lack of Efficacy             0             67             33
Lost to Follow-up             0             8             8
Other             0             2             0
Protocol Violation             0             8             5
Withdrawal by Subject             0             6             12
[1]
2 participants randomized in error to DB, then entered OL Taper; counted in OL Taper and DB phases.
Period Title: DB Taper Phase / Post Study Follow Up
Started 0 267 [1] 265
Did Not Enter DB Taper 0 9 7
Discontinued DB Taper 0 41 [2] 30
Completed 0 226 235
Not Completed 0 41 30
Reason Not Completed
Adverse Event             0             5             0
Failed to return             0             5             4
Physician Decision             0             6             0
Lost to Follow-up             0             2             2
Other             0             11             12
Protocol Violation             0             4             1
Withdrawal by Subject             0             8             11
[1]
Double-blind participants (DBp) could have entered 7-day taper period at any time during DB phase.
[2]
DBp could have discontinued at anytime during DB taper period or Follow-up (7 days after last dose).
Arm/Group Title DVS SR 50 mg (Open-label Phase) Placebo (Double-blind Phase) DVS SR 50 mg (Double-blind Phase) Total
Hide Arm/Group Description DVS SR 50 mg PO QD for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).

Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.

Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population).

Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.

DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population).

Total of all reporting groups
Overall Number of Baseline Participants 874 276 272 1422
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 874 participants 276 participants 272 participants 1422 participants
44.98  (13.25) NA [2]   (NA) NA [2]   (NA) 44.98  (13.25)
[1]
Measure Description: OL Baseline All Enrolled Population
[2]
Baseline Age reported for participants entering the Open-label phase at study start.
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 874 participants 276 participants 272 participants 1422 participants
Female 608 0 0 608
Male 266 0 0 266
[1]
Measure Description: OL Baseline All Enrolled Population. Baseline Gender reported for participants entering the Open-label phase at study start.
Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 874 participants 276 participants 272 participants 1422 participants
1=very much improved 0 239 223 462
2=much improved 0 36 49 85
3=minimally improved 0 1 0 1
4=no change 0 0 0 0
5=minimally worse 0 0 0 0
6=much worse 0 0 0 0
7=very much worse 0 0 0 0
[1]
Measure Description: CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Outcome measure CGI-I results reported for DB phase; CGI-I baseline=DB baseline.
Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 874 participants 276 participants 272 participants 1422 participants
NA [2]   (NA) 4.58  (3.02) 4.69  (2.97) 4.64  (2.99)
[1]
Measure Description: HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression.
[2]
Outcome measure HAM-D17 results reported for DB phase; HAM-D17 baseline=DB baseline.
Number of participants with remission based on HAM-D17 score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 874 participants 276 participants 272 participants 1422 participants
Remission=No 0 46 52 98
Remission=Yes 0 230 220 450
[1]
Measure Description: HAM-D17: standardized, clinician-administered rating scale that assesses 17 items associated with major depression (such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items scored on 3 point scale (0=none/absent to 2=most severe) and 8 items scored on 5 point scale (0=none/absent to 4=most severe) for maximum total score of 50; higher score indicates more depression. Remission (Yes or No) based on HAMD-17 total score ≤7. Outcome measure HAM-D17 Remission results reported for DB phase; HAM-D17 Remission baseline=DB baseline.
1.Primary Outcome
Title Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185
Hide Description Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325).
Time Frame Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized population: all participants randomly assigned to the Double-blind treatment phase of the study.
Arm/Group Title Placebo DVS SR 50 mg
Hide Arm/Group Description:
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
Overall Number of Participants Analyzed 276 272
Measure Type: Number
Unit of Measure: percent estimated probability
30.2 14.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Significance declared if p-value ≤0.05. The estimated probability obtained via Kaplan-Meier estimate.
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale
Hide Description CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Time Frame Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized population. N=number of participants with analyzable data at observation (Observed Cases).
Arm/Group Title Placebo DVS SR 50 mg
Hide Arm/Group Description:
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD..
Overall Number of Participants Analyzed 267 261
Measure Type: Number
Unit of Measure: participants
DB Week 1: 1=very much improved 9 3
DB Week 1: 2=much improved 1 3
DB Week 1: 3=minimally improved 12 19
DB Week 1: 4=no change 227 212
DB Week 1: 5=minimally worse 16 20
DB Week 1: 6=much worse 2 3
DB Week 1: 7=very much worse 0 1
DB Week 2: 1=very much improved 7 3
DB Week 2: 2=much improved 5 6
DB Week 2: 3=minimally improved 15 24
DB Week 2: 4=no change 183 197
DB Week 2: 5=minimally worse 32 25
DB Week 2: 6=much worse 15 4
DB Week 2: 7=very much worse 0 0
DB Week 3: 1=very much improved 5 6
DB Week 3: 2=much improved 5 8
DB Week 3: 3=minimally improved 17 27
DB Week 3: 4=no change 169 185
DB Week 3: 5=minimally worse 45 24
DB Week 3: 6=much worse 6 2
DB Week 3: 7=very much worse 0 0
DB Week 4: 1=very much improved 5 8
DB Week 4: 2=much improved 6 7
DB Week 4: 3=minimally improved 20 28
DB Week 4: 4=no change 169 181
DB Week 4: 5=minimally worse 39 20
DB Week 4: 6=much worse 6 2
DB Week 4: 7=very much worse 1 1
DB Week 6: 1=very much improved 6 9
DB Week 6: 2=much improved 5 11
DB Week 6: 3=minimally improved 20 31
DB Week 6: 4=no change 153 174
DB Week 6: 5=minimally worse 40 16
DB Week 6: 6=much worse 14 6
DB Week 6: 7=very much worse 0 0
DB Week 10: 1=very much improved 3 7
DB Week 10: 2=much improved 4 9
DB Week 10: 3=minimally improved 19 28
DB Week 10: 4=no change 140 161
DB Week 10: 5=minimally worse 46 28
DB Week 10: 6=much worse 9 8
DB Week 10: 7=very much worse 1 1
DB Week 14: 1=very much improved 3 4
DB Week 14: 2=much improved 5 10
DB Week 14: 3=minimally improved 16 29
DB Week 14: 4=no change 124 159
DB Week 14: 5=minimally worse 49 25
DB Week 14: 6=much worse 10 3
DB Week 14: 7=very much worse 0 0
DB Week 18: 1=very much improved 6 7
DB Week 18: 2=much improved 6 6
DB Week 18: 3=minimally improved 12 28
DB Week 18: 4=no change 117 151
DB Week 18: 5=minimally worse 39 24
DB Week 18: 6=much worse 12 6
DB Week 18: 7=very much worse 0 1
DB Week 22: 1=very much improved 7 8
DB Week 22: 2=much improved 4 6
DB Week 22: 3=minimally improved 13 29
DB Week 22: 4=no change 116 139
DB Week 22: 5=minimally worse 30 28
DB Week 22: 6=much worse 13 5
DB Week 22: 7=very much worse 1 0
DB Week 26: 1=very much improved 7 9
DB Week 26: 2=much improved 7 10
DB Week 26: 3=minimally improved 13 29
DB Week 26: 4=no change 105 135
DB Week 26: 5=minimally worse 31 22
DB Week 26: 6=much worse 10 5
DB Week 26: 7=very much worse 1 0
3.Secondary Outcome
Title Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase
Hide Description CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range of 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected. Change from baseline mean=adjusted mean change calculated using mixed-effects model for repeated measures (MMRM).
Time Frame Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized population. N=number of participants with analyzable data at observation.
Arm/Group Title Placebo DVS SR 50 mg
Hide Arm/Group Description:
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
Overall Number of Participants Analyzed 267 261
Mean (Standard Error)
Unit of Measure: scores on a scale
Change from Baseline at DB Week 1 0.03  (0.03) 0.03  (0.03)
Change from Baseline at DB Week 2 0.18  (0.04) 0.09  (0.04)
Change from Baseline at DB Week 3 0.21  (0.04) 0.07  (0.04)
Change from Baseline at DB Week 4 0.23  (0.05) 0.06  (0.05)
Change from Baseline at DB Week 6 0.32  (0.05) 0.06  (0.05)
Change from Baseline at DB Week 10 0.39  (0.06) 0.11  (0.06)
Change from Baseline at DB Week 14 0.38  (0.05) 0.05  (0.05)
Change from Baseline at DB Week 18 0.42  (0.06) 0.09  (0.06)
Change from Baseline at DB Week 22 0.56  (0.07) 0.13  (0.07)
Change from Baseline at DB Week 26 0.53  (0.06) 0.09  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9627
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.00
Confidence Interval (2-Sided) 95%
-0.09 to 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1046
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.02 to 0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0228
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
0.02 to 0.25
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0064
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
0.05 to 0.29
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
0.11 to 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
0.12 to 0.43
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.19 to 0.47
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.17 to 0.49
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 22
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.25 to 0.62
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
0.28 to 0.61
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase
Hide Description HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.
Time Frame Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized population. N=number of participants with analyzable data at observation.
Arm/Group Title Placebo DVS SR 50 mg
Hide Arm/Group Description:
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
Overall Number of Participants Analyzed 267 261
Mean (Standard Error)
Unit of Measure: scores on a scale
Change from Baseline at DB Week 1 0.28  (0.17) 0.25  (0.17)
Change from Baseline at DB Week 2 1.40  (0.24) 0.53  (0.24)
Change from Baseline at DB Week 3 1.32  (0.22) 0.45  (0.23)
Change from Baseline at DB Week 4 1.50  (0.24) 0.11  (0.24)
Change from Baseline at DB Week 6 1.94  (0.28) 0.31  (0.28)
Change from Baseline at DB Week 10 2.37  (0.32) 0.69  (0.31)
Change from Baseline at DB Week 14 2.66  (0.30) 0.62  (0.30)
Change from Baseline at DB Week 18 2.51  (0.33) 0.56  (0.32)
Change from Baseline at DB Week 22 3.22  (0.37) 0.92  (0.36)
Change from Baseline at DB Week 26 3.12  (0.36) 0.77  (0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8853
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.41 to 0.47
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0081
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.23 to 1.52
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.28 to 1.47
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.39
Confidence Interval (2-Sided) 95%
0.76 to 2.03
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.63
Confidence Interval (2-Sided) 95%
0.86 to 2.39
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.68
Confidence Interval (2-Sided) 95%
0.83 to 2.54
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.04
Confidence Interval (2-Sided) 95%
1.23 to 2.86
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.95
Confidence Interval (2-Sided) 95%
1.06 to 2.84
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 22
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.30
Confidence Interval (2-Sided) 95%
1.31 to 3.30
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.35
Confidence Interval (2-Sided) 95%
1.39 to 3.32
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase
Hide Description HAM-D6 is a standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.
Time Frame Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized population. N=number of participants with analyzable data at observation.
Arm/Group Title Placebo DVS SR 50 mg
Hide Arm/Group Description:
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
Overall Number of Participants Analyzed 267 261
Mean (Standard Error)
Unit of Measure: scores on a scale
Change from baseline at DB Week1 0.03  (0.10) 0.01  (0.10)
Change from baseline at DB Week 2 0.66  (0.14) 0.13  (0.14)
Change from baseline at DB Week 3 0.72  (0.14) 0.14  (0.14)
Change from baseline at DB Week 4 0.92  (0.15) 0.03  (0.15)
Change from baseline at DB Week 6 1.04  (0.17) 0.16  (0.16)
Change from baseline at DB Week 10 1.41  (0.19) 0.33  (0.18)
Change from baseline at DB Week 14 1.47  (0.17) 0.34  (0.17)
Change from baseline at DB Week 18 1.51  (0.20) 0.21  (0.19)
Change from baseline at DB Week 22 1.68  (0.20) 0.45  (0.19)
Change from baseline at DB Week 26 1.53  (0.20) 0.26  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9142
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.24 to 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0069
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.15 to 0.91
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.21 to 0.95
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.49 to 1.28
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.43 to 1.32
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.58 to 1.58
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.66 to 1.58
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.30
Confidence Interval (2-Sided) 95%
0.76 to 1.83
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 22
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
0.70 to 1.76
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.75 to 1.79
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26
Hide Description HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Remission defined as HAM-D17 total score ≤7.
Time Frame Double-blind phase Week 26 (Study Day 322)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized population. N=number of participants with analyzable data at observation based on Last Observation Carried Forward (LOCF).
Arm/Group Title Placebo DVS SR 50 mg
Hide Arm/Group Description:
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
Overall Number of Participants Analyzed 273 270
Measure Type: Number
Unit of Measure: participants
148 201
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Wald 95% CI for adjusted odds ratio.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Obtained from logistic regression analysis using Remission (Yes/No) at each time point as a response variable; logistic model with treatment and sites as factors and baseline HAM-D17 total score as covariate.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted odds ratio
Estimated Value 2.85
Confidence Interval (2-Sided) 95%
1.93 to 4.20
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index
Hide Description WHO-5 evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions (felt cheerful, in good spirits; felt calm, relaxed; felt active, vigorous; woke up fresh, rested; and daily life filled with things that are interesting) each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score ranged from 0 (worst possible quality of life) to 25 (best possible quality of life). Change from baseline mean=adjusted mean change calculated using MMRM.
Time Frame Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized population. N=number of participants with analyzable data at observation.
Arm/Group Title Placebo DVS SR 50 mg
Hide Arm/Group Description:
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
Overall Number of Participants Analyzed 265 261
Mean (Standard Error)
Unit of Measure: scores on a scale
Change from baseline at DB Week 14 -2.51  (0.35) -0.38  (2.36)
Change from baseline at DB Week 26 -2.36  (0.38) -0.04  (0.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.14
Confidence Interval (2-Sided) 95%
-3.03 to -1.24
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.32
Confidence Interval (2-Sided) 95%
-3.29 to -1.34
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase
Hide Description WPAI is a 6 question participant rated questionnaire to determine the degree to which depression affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher score indicated greater impairment and less productivity.
Time Frame Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized population. Change from baseline (Bsl) mean=adjusted mean change calculated using MMRM.
Arm/Group Title Placebo DVS SR 50 mg
Hide Arm/Group Description:
Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
Overall Number of Participants Analyzed 265 261
Mean (Standard Error)
Unit of Measure: scores on a scale
Change from Bsl at DB Week 14: Absenteeism 1.64  (1.72) 0.62  (1.87)
Change from Bsl at DB Week 14: Presenteeism 9.35  (2.30) 2.44  (2.55)
Change from Bsl DB Week 14: Work productivity loss 9.66  (2.48) 2.19  (2.75)
Change from Bsl at DB Week 14: Activity impairment 11.02  (1.62) 3.45  (1.66)
Change from Bsl at DB Week 26: Absenteeism 0.43  (2.05) 0.77  (2.08)
Change from Bsl at DB Week 26: Presenteeism 7.75  (2.35) -0.49  (2.41)
Change from Bsl DB Week 26: Work productivity loss 8.47  (2.56) -0.00  (2.63)
Change from Bsl at DB Week 26: Activity impairment 9.67  (1.75) 2.05  (1.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 14 Absenteeism
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6772
Comments P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
-3.82 to 5.87
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 26 Absenteeism
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9059
Comments P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-5.91 to 5.24
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 14 Presenteeism
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0414
Comments P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.91
Confidence Interval (2-Sided) 95%
0.27 to 13.55
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 26 Presenteeism
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0129
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.24
Confidence Interval (2-Sided) 95%
1.77 to 14.71
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 14 Work Productivity Loss
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0402
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.48
Confidence Interval (2-Sided) 95%
0.34 to 14.61
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 26 Work Productivity Loss
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0187
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.48
Confidence Interval (2-Sided) 95%
1.43 to 15.53
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 14 Activity Impairment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.57
Confidence Interval (2-Sided) 95%
3.33 to 11.80
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, DVS SR 50 mg
Comments Adjusted difference from placebo: Week 26 Activity Impairment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with "Unstructured" covariance structure.
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures (MMRM).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.62
Confidence Interval (2-Sided) 95%
3.14 to 12.10
Estimation Comments [Not Specified]
Time Frame Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.
Adverse Event Reporting Description Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.
 
Arm/Group Title DVS SR 50 mg (Open-label Response Phase) DVS SR 50 mg (Open Label Stability Phase) DVS SR 50 mg (Open Label Taper / OL Post Study Follow Up) Placebo (Double-blind Phase) DVS SR 50 mg (Double-blind Phase) Placebo (DB Taper / DB Post Study Follow Up) DVS SR 50 mg (DB Taper / DB Post Study Follow Up)
Hide Arm/Group Description DVS SR 50 mg PO QD for 8 weeks. DVS SR 50 mg PO QD; Responders at week 8 entered a 12-week stability phase. Participants who concluded DVS SR 50 mg open-label study or discontinued treatment at any time in OLR or OLS could have entered the taper phase and received DVS SR 25 mg PO QD for a 7-day period of taper treatment. N=number of participants with OL Taper or OL Post Study Follow Up emergent events who did not enter the DB Phase and concluded or discontinued with or without taper treatment. Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD. DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD. Participants who concluded or discontinued placebo during the DB phase could have entered the taper phase and received placebo matching DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment. Participants who concluded or discontinued DVS SR 50 mg during the DB phase could have entered the taper phase and received DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
All-Cause Mortality
DVS SR 50 mg (Open-label Response Phase) DVS SR 50 mg (Open Label Stability Phase) DVS SR 50 mg (Open Label Taper / OL Post Study Follow Up) Placebo (Double-blind Phase) DVS SR 50 mg (Double-blind Phase) Placebo (DB Taper / DB Post Study Follow Up) DVS SR 50 mg (DB Taper / DB Post Study Follow Up)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DVS SR 50 mg (Open-label Response Phase) DVS SR 50 mg (Open Label Stability Phase) DVS SR 50 mg (Open Label Taper / OL Post Study Follow Up) Placebo (Double-blind Phase) DVS SR 50 mg (Double-blind Phase) Placebo (DB Taper / DB Post Study Follow Up) DVS SR 50 mg (DB Taper / DB Post Study Follow Up)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/874 (1.03%)   6/659 (0.91%)   4/326 (1.23%)   7/276 (2.54%)   8/272 (2.94%)   1/276 (0.36%)   1/272 (0.37%) 
Blood and lymphatic system disorders               
Anaemia * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  1/272 (0.37%)  0/276 (0.00%)  0/272 (0.00%) 
Cardiac disorders               
Atrioventricular block second degree * 1  1/874 (0.11%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Tachycardia * 1  0/874 (0.00%)  1/659 (0.15%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Atrial fibrillation * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  1/276 (0.36%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Myocardial infarction * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  1/276 (0.36%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
General disorders               
Non−cardiac chest pain * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  1/276 (0.36%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Pyrexia * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  1/276 (0.36%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Infections and infestations               
Subcutaneous abscess * 1  1/874 (0.11%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Viral infection * 1  0/874 (0.00%)  1/659 (0.15%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Genital infection bacterial * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  1/276 (0.36%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Pelvic inflammatory disease * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  1/272 (0.37%)  0/276 (0.00%)  0/272 (0.00%) 
Pyelonephritis acute * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  1/272 (0.37%)  0/276 (0.00%)  0/272 (0.00%) 
Diverticulitis * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  1/276 (0.36%)  0/272 (0.00%) 
Injury, poisoning and procedural complications               
Intentional overdose * 1  2/874 (0.23%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Ankle fracture * 1  0/874 (0.00%)  1/659 (0.15%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Concussion * 1  0/874 (0.00%)  1/659 (0.15%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Fall * 1  0/874 (0.00%)  1/659 (0.15%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Subdural haematoma * 1  0/874 (0.00%)  1/659 (0.15%)  0/326 (0.00%)  0/276 (0.00%)  1/272 (0.37%)  0/276 (0.00%)  0/272 (0.00%) 
Rib fracture * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  1/276 (0.36%)  1/272 (0.37%)  0/276 (0.00%)  0/272 (0.00%) 
Tibia fracture * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  1/272 (0.37%)  0/276 (0.00%)  0/272 (0.00%) 
Road traffic accident * 1 [1]  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  1/272 (0.37%) 
Metabolism and nutrition disorders               
Dehydration * 1  0/874 (0.00%)  1/659 (0.15%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Musculoskeletal and connective tissue disorders               
Cervical spinal stenosis * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  1/272 (0.37%)  0/276 (0.00%)  0/272 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Bladder cancer * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  1/276 (0.36%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Breast cancer * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  1/272 (0.37%)  0/276 (0.00%)  0/272 (0.00%) 
Colon cancer * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  1/272 (0.37%)  0/276 (0.00%)  0/272 (0.00%) 
Nervous system disorders               
Intracranial aneurysm * 1  0/874 (0.00%)  1/659 (0.15%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Loss of consciousness * 1  0/874 (0.00%)  1/659 (0.15%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Partial seizures * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  1/272 (0.37%)  0/276 (0.00%)  0/272 (0.00%) 
Pregnancy, puerperium and perinatal conditions               
Abortion spontaneous * 1  0/874 (0.00%)  0/659 (0.00%)  1/326 (0.31%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Intrauterine death * 1  0/874 (0.00%)  0/659 (0.00%)  1/326 (0.31%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Psychiatric disorders               
Abnormal behaviour * 1  1/874 (0.11%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Aggression * 1  1/874 (0.11%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Depressive symptom * 1  1/874 (0.11%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Suicidal ideation * 1  2/874 (0.23%)  2/659 (0.30%)  1/326 (0.31%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Suicide attempt * 1  2/874 (0.23%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Depression * 1  0/874 (0.00%)  1/659 (0.15%)  1/326 (0.31%)  1/276 (0.36%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Self injurious behaviour * 1  0/874 (0.00%)  1/659 (0.15%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Alcohol abuse * 1  0/874 (0.00%)  0/659 (0.00%)  1/326 (0.31%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Renal and urinary disorders               
Haematuria * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  1/276 (0.36%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Reproductive system and breast disorders               
Benign prostatic hyperplasia * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  1/276 (0.36%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Skin and subcutaneous tissue disorders               
Angioedema * 1  1/874 (0.11%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
[1]
Outcome: Death
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DVS SR 50 mg (Open-label Response Phase) DVS SR 50 mg (Open Label Stability Phase) DVS SR 50 mg (Open Label Taper / OL Post Study Follow Up) Placebo (Double-blind Phase) DVS SR 50 mg (Double-blind Phase) Placebo (DB Taper / DB Post Study Follow Up) DVS SR 50 mg (DB Taper / DB Post Study Follow Up)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   609/874 (69.68%)   36/659 (5.46%)   8/326 (2.45%)   81/276 (29.35%)   55/272 (20.22%)   14/276 (5.07%)   23/272 (8.46%) 
Gastrointestinal disorders               
Constipation * 1  51/874 (5.84%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Diarrhoea * 1  44/874 (5.03%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Dry mouth * 1  104/874 (11.90%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Nausea * 1  184/874 (21.05%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  1/276 (0.36%)  7/272 (2.57%) 
Nervous system disorders               
Dizziness * 1  62/874 (7.09%)  0/659 (0.00%)  0/326 (0.00%)  29/276 (10.51%)  13/272 (4.78%)  1/276 (0.36%)  13/272 (4.78%) 
Headache * 1  160/874 (18.31%)  36/659 (5.46%)  8/326 (2.45%)  35/276 (12.68%)  34/272 (12.50%)  4/276 (1.45%)  7/272 (2.57%) 
Somnolence * 1  45/874 (5.15%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Psychiatric disorders               
Insomnia * 1  44/874 (5.03%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
Depression * 1  0/874 (0.00%)  0/659 (0.00%)  0/326 (0.00%)  17/276 (6.16%)  8/272 (2.94%)  9/276 (3.26%)  3/272 (1.10%) 
Skin and subcutaneous tissue disorders               
Hyperhidrosis * 1  50/874 (5.72%)  0/659 (0.00%)  0/326 (0.00%)  0/276 (0.00%)  0/272 (0.00%)  0/276 (0.00%)  0/272 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
P-value from the primary analysis is different from the one testing equality of relapse rates on Double-blind day 185. Estimated percentages were provided as representative descriptive measures. Medians were not estimable due to low relapse rates.
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
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00887224     History of Changes
Other Study ID Numbers: 3151A1-3360
B2061004
First Submitted: April 22, 2009
First Posted: April 23, 2009
Results First Submitted: March 6, 2012
Results First Posted: June 27, 2012
Last Update Posted: November 21, 2014