A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder

Wyeth is now a wholly owned subsidiary of Pfizer0 sites603 target enrollmentJanuary 9, 2004

ConditionsMajor Depressive Disorder

DrugsDVS-233 SR

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 603
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Primary Objective: To compare the efficacy and safety of DVS-233 SR versus placebo treatment in reducing the relapse rate of depressive symptoms in subjects with major depressive disorder (MDD), and to compare the percentages of relapse in terms of time to relapse between DVS-233 SR and placebo treatment groups by using survival analysis.

Secondary Objective: To assess the response of subjects on DVS-233 SR versus placebo for the clinical global evaluation, functionality, general well-being, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] < 7).

Registry

clinicaltrials.gov

Start Date

January 9, 2004

End Date

August 2005

Last Updated

16 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

Not provided

Exclusion Criteria

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