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

Wyeth

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Depression

Depressive Disorder

Treatments

Drug: DVS-233 SR

Study type

Interventional

Funder types

Industry

Identifiers

NCT00092911

3151A1-320

Details and patient eligibility

About

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.

Enrollment

244 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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