Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00073762
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

Primary Objective: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.

Secondary Objective: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general wellbeing, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item \[HAM-D17\] less than or equal to 7) versus those subjects receiving placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-12-04
• Study First Submitted QC: 2003-12-07
• Study First Posted: 2003-12-08
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-18
• Last Update Posted: 2009-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

• Outpatients
• Sexually active women participating in the study must use a medically acceptable form of contraception
• Subjects must have a primary diagnosis of major depressive disorder of 4 on Clinical Global Impressions-Severity scale (CGI-S)

Exclusion Criteria

• Treatment with DVS-233 SR at any time in the past
• Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1
• Known hypersensitivity to venlafaxine (IR or ER)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL