Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) in the Treatment of Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR); Drug: placebo

• Registration Number: NCT00798707
• Lead Sponsor: Pfizer

Brief Summary

The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Study First Posted: 2008-11-26
• Study Start: 2008-12
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-03-07
• Results First Submitted QC: 2011-05-12
• Status Verified: 2011-06
• Results First Posted: 2011-06-06
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 709

Inclusion Criteria

• Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening)
• Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20
• Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4

Exclusion Criteria

• Clinical instability - 25% or greater increase/decrease in HAM-D 17 total score from screening to baseline
• Significant risk of suicide as assessed by clinician judgement, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desvenlafaxine succinate sustained-release 25 mg	Desvenlafaxine Succinate Sustained-Release (DVS SR)	-
Desvenlafaxine succinate sustained-release 50 mg	Desvenlafaxine Succinate Sustained-Release (DVS SR)	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)	Baseline and Week 8 (or ET)	HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)	Week 8 (or ET)	CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)	Baseline and Week 8 (or ET)	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)	Baseline and Week 8 (or ET)	MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)	Baseline and Week 8 (or ET)	HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.
Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)	Week 8 (or ET)	A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)	Week 8 (or ET)	Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)	Week 8 (or ET)	A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)	Week 8 (or ET)	CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Saitama, Japan