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

Phase 3

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00090649
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

To compare the antidepressant efficacy and safety of DVS-233 SR with those of placebo in adult outpatients with MDD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-08-31
• Study First Submitted QC: 2004-08-31
• Study First Posted: 2004-09-01
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-18
• Last Update Posted: 2009-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 369

Inclusion Criteria

• Men and women 18 to 75 years of age, inclusive.
• Sexually active individuals participating in the study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article
• Subjects must have a primary diagnosis of major depressive disorder

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