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

Phase 3

Completed

• Conditions: Depression; Depressive Disorder; Major Depressive Disorder

• Registration Number: NCT00092911
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The main objective of this study is to compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with Major Depressive Disorder.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-09-24
• Study First Submitted QC: 2004-09-27
• Study First Posted: 2004-09-28
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-18
• Last Update Posted: 2009-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

• Outpatients
• Men and women age 18 years of age and older
• Women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception

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)
• Significant risk of suicide based on clinical judgment, including common

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL