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

Phase 3

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00277823
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS-SR versus subjects receiving placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-16
• Study Start: 2006-02
• Study Completion: 2007-01
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-19
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• Clinical diagnosis of major depressive disorder
• Must be able to swallow tablets
• Must be at least 18 years of age.

Exclusion Criteria

• Clinical diagnosis of other psychiatric disorders
• Significant risk of suicide
• Unstable medical conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo.

Secondary Outcome Measures

Name	Time	Method
Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.