An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive Disorder - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00057213

Purpose

A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)

Condition	Intervention	Phase
Major Depressive Disorder (MDD)	Drug: Radafaxine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible-Dose Study Evaluating Efficacy, Safety, and Tolerability of Once-Daily Oral GW353162 (20-40-60mg) Versus Placebo in Subjects With Major Depressive Disorder Over an Eight-Week Treatment Period.

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Radafaxine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change in the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks of treatment [ Time Frame: 8 Weeks ]

Secondary Outcome Measures:

Change in the MADRS score at other timepoints; change in Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy, fatigue and pain;incidence of adverse events over course of study;

Estimated Enrollment:	364
Study Start Date:	March 2003

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Major Depressive Disorder (MDD)
Duration of current depressive episode 12 weeks - 24 months
Patients can read and write at a level sufficient to provide a signed consent
If female, patients must be practicing an acceptable method of birth control

Exclusion Criteria:

Patients have other psychiatric disorders that would affect patient's response to treatment
Patients have not responded to two or more adequate courses of antidepressant therapy
Patients cannot be currently abusing illicit drugs or alcohol
Patients are not currently receiving psychotherapy
Patients have received electroconvulsive therapy within 6 months prior to screening
Patients are pregnant or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057213

Locations

United States, Arizona
GSK Investigational Site
Peoria, Arizona, United States, 85381 - 4828
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
United States, California
GSK Investigational Site
National City, California, United States, 91950
GSK Investigational Site
Irvine, California, United States, 92618
GSK Investigational Site
Garden Grove, California, United States, 92845
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33173
GSK Investigational Site
Winter Park, Florida, United States, 32789
United States, Illinois
GSK Investigational Site
Springfield, Illinois, United States, 62702
United States, Indiana
GSK Investigational Site
Terre Haute, Indiana, United States, 47802
United States, Kentucky
GSK Investigational Site
Florence, Kentucky, United States, 41042
United States, Massachusetts
GSK Investigational Site
Brockton, Massachusetts, United States, 2301
United States, New York
GSK Investigational Site
New York, New York, United States, 10021
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
GSK Investigational Site
Lyndhurst, Ohio, United States, 44124
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19106
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78756
GSK Investigational Site
Galveston, Texas, United States, 77555
GSK Investigational Site
Lake Jackson, Texas, United States, 77566
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84107

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	OHB20002
Study First Received:	March 27, 2003
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00057213 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

GW353162,
Major Depressive Disorder (MDD),
Flexible

Additional relevant MeSH terms:

Pathologic Processes
Disease
Depression
Mental Disorders

Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 09, 2009