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

Purpose

Primary Objective: To compare the efficacy and safety of DVS-233 SR versus placebo treatment in reducing the relapse rate of depressive symptoms in subjects with major depressive disorder (MDD), and to compare the percentages of relapse in terms of time to relapse between DVS-233 SR and placebo treatment groups by using survival analysis.

Secondary Objective: To assess the response of subjects on DVS-233 SR versus placebo for the clinical global evaluation, functionality, general well-being, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] < 7).

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, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder

Further study details as provided by Wyeth:

Estimated Study Completion Date:

August 2005

Eligibility

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

Criteria

Inclusion criteria in the open-label phase:

Outpatients
Men and women 18 to 75 years of age, inclusive. Sexually active women participating in the study must use a medically acceptable form of contraception (Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception)
Subjects must have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent episode, without psychotic features (If other allowable psychiatric diagnoses are present, MDD must be the predominant psychiatric disorder present.)

Exclusion Criteria:

Treatment with DVS-233 SR at any time in the past
Treatment with venlafaxine (immediate release [IR] or 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: NCT00075257

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor, MD	Wyeth

More Information

Study ID Numbers:	3151A1-302
First Received:	January 7, 2004
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00075257
Health Authority:	United States: Food and Drug Administration

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

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00075257