A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy And Safety Of 2 Fixed Doses (10 And 50 mg/Day) Of DVS SR Tablets In Adult Outpatients With Major Depressive Disorder

Wyeth is now a wholly owned subsidiary of Pfizer1 site in 1 country682 target enrollmentApril 2009

ConditionsMajor Depressive Disorder

InterventionsDesvenlafaxine Succinate Sustained-Release 10mg Desvenlafaxine Succinate Sustained-Release 50 mg placebo

DrugsDesvenlafaxine Succinate Sustained-Release 10mg Desvenlafaxine Succinate Sustained-Release 50 mg placebo

Overview

Phase: Phase 3
Intervention: Desvenlafaxine Succinate Sustained-Release 10mg
Conditions: Major Depressive Disorder
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 682
Locations: 1
Primary Endpoint: Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

March 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

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 \>=
•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 judgment, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply.

Arms & Interventions

Desvenlafaxine succinate sustained release 10 mg

Intervention: Desvenlafaxine Succinate Sustained-Release 10mg

Desvenlafaxine succinate sustained release 50 mg

Intervention: Desvenlafaxine Succinate Sustained-Release 50 mg

Placebo

Intervention: placebo

Outcomes

Primary Outcomes

Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)

Time Frame: 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 Outcomes

Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)(Week 8 (or ET))
Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)(Baseline and Week 8 (or ET ))
Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)(Baseline and Week 8 (or ET))
Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)(Baseline and Week 8 (or ET ))
Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)(Week 8 (or ET))
Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)(Week 8 (or ET))
Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)(Week 8 (or ET))
Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)(Week 8 (or ET))