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

This study has been completed.

First Received on January 7, 2004. Last Updated on August 18, 2009 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00075257

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Enrollment:	603
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (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 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 is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor, MD

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00075257 History of Changes
Other Study ID Numbers:	3151A1-302
Study First Received:	January 7, 2004
Last Updated:	August 18, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major

Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on February 09, 2012