A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Two Fixed Doses (200 Mg, Or 400 Mg) Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Wyeth is now a wholly owned subsidiary of Pfizer0 sites375 target enrollmentDecember 8, 2003

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: 375
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 8, 2003

End Date

September 2004

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

•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)