Duloxetine Referenced Study Evaluating the Efficacy and Safety of 50 mg & 100 mg Doses of DVS SR in Outpatients With MDD - Full Text View

Purpose

This research study is for outpatient men and women age 18 and older with major depressive disorder (MDD). This study involves the experimental drug desvenlafaxine succinate sustained release (DVS SR).

The purpose of this study is to learn if DVS SR is safe and effective for people with major depressive disorder.

DVS SR affects the activity of 2 neurotransmitters (active chemicals released by the neurons), serotonin and norepinephrine, in your brain. The reference medication used in this study, a currently marketed drug called duloxetine, is an antidepressant medication in the same class as DVS SR, and also affects the activity of serotonin and norephinephrine in the brain.

Participants in this study will be randomly assigned either to receive one of two doses of DVS SR, duloxetine, or placebo.

Participation in the study is voluntary and can last for up to approximately 12 weeks.

Condition	Intervention	Phase
Depressive Disorder, Major	Drug: Desvenlafaxine Sustained-Release Tablets	Phase III

MedlinePlus related topics:

Depression

Drug Information available for:

Desvenlafaxine Succinate Desvenlafaxine Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Duloxetine-Referenced, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50mg, 100mg) of Desvenlafaxine Sustained-Release Tables in Adult Outpatients With Major Depressive Disorder

Further study details as provided by Wyeth:

Primary Outcome Measures:

The primary study objective is to investigate DVS SR at doses of 50 and 100 mg to evaluate efficacy, safety and tolerability at the lower dose range.

Estimated Enrollment:	640
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.
Depressive symptoms for at least 30 days before the screening visit.
Outpatient men and women at least 18 years of age.

Exclusion Criteia:

Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384033

Locations


United States, California

	Newport Beach, California, United States, 92660

	Northridge, California, United States, 91324

	Pasadena, California, United States, 91105

	Burbank, California, United States, 91506

	Beverly Hills, California, United States, 90210

	Los Alamitos, California, United States, 90720

	Orange, California, United States, 92868

	Upland, California, United States, 91786

United States, Florida

	St. Petersburg, Florida, United States, 33702

	Miami, Florida, United States, 33143

United States, Illinois

	Edwardsville, Illinois, United States, 62025

United States, Michigan

	Farmington Hills, Michigan, United States, 48336

	Flint, Michigan, United States, 48507

	Okemos, Michigan, United States, 48864

United States, New Jersey

	Clementon, New Jersey, United States, 08021

United States, Ohio

	Dayton, Ohio, United States, 45408

United States, Oregon

	Portland, Oregon, United States, 97210

United States, Pennsylvania

	Philadelphia, Pennsylvania, United States, 19149

United States, Utah

	Salt Lake City, Utah, United States, 84107

United States, Washington

	Seattle, Washington, United States, 98104

United States, Wisconsin

	Brown Deer, Wisconsin, United States, 53223

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Study ID Numbers:	3151A1-335
First Received:	October 2, 2006
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00384033
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

MDD

Major Depressive Disorder

Depression

Study placed in the following topic categories:

Depression

O-desmethylvenlafaxine

Mental Disorders

Mood Disorders

Depressive Disorder, Major

Depressive Disorder

Duloxetine

Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Pathologic Processes

Disease

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Agents

Antidepressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00384033