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

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

This study is ongoing, but not recruiting participants.

Sponsored by:	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

MedlinePlus related topics:

Depression

U.S. FDA Resources

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

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

Publications indexed to this study:

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
First Received:	June 23, 2003
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00063206
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Depressive Disorder, Major

Depression, Involutional

Study placed in the following topic categories:

Depression

Mental Disorders

Mood Disorders

Depressive Disorder, Major

Depressive Disorder

Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on November 30, 2008