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

This study has been completed.

First Received: June 23, 2003 Last Updated: August 18, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00063206

Purpose

Primary: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.

Secondary: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general well-being, pain, and remission (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D<sub>17</sub>] < 7) versus those subjects receiving placebo.

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

Study Type:	Interventional
Study Design:	Treatment
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:	247
Study Completion Date:	May 2004
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must have a primary diagnosis of major depressive disorder (MDD)
Depressive symptoms for at least 30 days prior to the screening visit
Minimum screening and study day -1 (baseline) scores of 20 on the Hamilton Psychiatric Rating Scale for Depression (HAM D<sub>17</sub>)

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063206

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided by Wyeth

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Liebowitz MR, Yeung PP, Entsuah R. A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in adult outpatients with major depressive disorder. J Clin Psychiatry. 2007 Nov;68(11):1663-72.

Study ID Numbers:	3151A1-304
Study First Received:	June 23, 2003
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00063206 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Depressive Disorder, Major
Depression, Involutional

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 27, 2009