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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00057239

Purpose

A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Radafaxine 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 Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy, Safety and Tolerability of Two Doses (20mg and 60mg) of a Once-Daily Oral Formulation of GW353162 in Subjects With Major Depressive Disorder for a Treatment Period of Eight Weeks

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) score 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 and pain;incidence of adverse events over course of study. [ Time Frame: 8 Weeks ]

Estimated Enrollment:	546
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: NCT00057239

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Locations

United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72223
United States, California
GSK Investigational Site
Newport Beach, California, United States, 92660-2814
United States, Connecticut
GSK Investigational Site
Farmington, Connecticut, United States, 6708
United States, Florida
GSK Investigational Site
North Miami, Florida, United States, 33161
GSK Investigational Site
Miami, Florida, United States, 33156
GSK Investigational Site
Largo, Florida, United States, 33773
GSK Investigational Site
Maitland, Florida, United States, 32751
United States, Illinois
GSK Investigational Site
Edwardsville, Illinois, United States, 62025
United States, Maryland
GSK Investigational Site
Glen Burnie, Maryland, United States, 21061
United States, Michigan
GSK Investigational Site
Farmington Hills, Michigan, United States, 48336
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55454
United States, New Jersey
GSK Investigational Site
Clementon, New Jersey, United States, 08021
GSK Investigational Site
Kenilworth, New Jersey, United States, 07033
United States, New York
GSK Investigational Site
Lawrence, New York, United States, 11559
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28203
United States, Ohio
GSK Investigational Site
Dayton, Ohio, United States, 45408
GSK Investigational Site
Cleveland, Ohio, United States, 44106
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73118
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
GSK Investigational Site
Portland, Oregon, United States, 97209
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
GSK Investigational Site
Conshohocken, Pennsylvania, United States, 19428
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75235
GSK Investigational Site
Irving, Texas, United States, 75039
GSK Investigational Site
Houston, Texas, United States, 77004
United States, Vermont
GSK Investigational Site
Woodstock, Vermont, United States, 05091
United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98499
GSK Investigational Site
Seattle, Washington, United States, 98104
United States, Wisconsin
GSK Investigational Site
Brown Deer, Wisconsin, United States, 53223

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, M.D.

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	OHB20001
Study First Received:	March 27, 2003
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00057239 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

GW353162
Major Depressive Disorder
MDD

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 22, 2009