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

This study has been completed.

First Received: September 24, 2004 Last Updated: August 18, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00092911

Purpose

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.

Condition	Intervention	Phase
Depression Depressive Disorder Major Depressive Disorder	Drug: DVS-233 SR	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Wyeth:

Enrollment:	244
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092911

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	3151A1-320
Study First Received:	September 24, 2004
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00092911 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pathologic Processes
Disease
Depression
Mental Disorders

Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 09, 2009