A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of a Flexible Dose of DVS-233 SR in Adult Outpatients With Major Depressive Disorder

Wyeth is now a wholly owned subsidiary of Pfizer0 sites244 target enrollmentSeptember 28, 2004

ConditionsDepression Depressive Disorder Major Depressive Disorder

DrugsDVS-233 SR

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Depression
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 244
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 28, 2004

End Date

May 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

•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