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

This study is ongoing, but not recruiting participants.

First Received: August 31, 2004 Last Updated: May 18, 2006 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00090649

Purpose

To compare the antidepressant efficacy and safety of DVS-233 SR with those of placebo in adult outpatients with MDD.

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

MedlinePlus related topics: Depression

Drug Information available for: Venlafaxine Venlafaxine hydrochloride

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, Flexible-Dose Study Of DVS-233 SR And Venlafaxine ER 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:

Men and women 18 to 75 years of age, inclusive.
Sexually active individuals participating in the study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article
Subjects must have a primary diagnosis of major depressive disorder

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: NCT00090649

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	3151A1-309
Study First Received:	August 31, 2004
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00090649 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors
Serotonin

Behavioral Symptoms
Mental Disorders
Venlafaxine
Mood Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions

Behavioral Symptoms
Serotonin Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses
Venlafaxine
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 06, 2009