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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00057226

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 (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) score after 8 weeks of treatment [ Time Frame: 8 Weeks ]

Secondary Outcome Measures:

Change in the MADRS score at other timepoints; change in the Global Impression; percentage of remitters and responders based on the MADRS; change in anxiety, disability, motivation, energy, fatigue and pain; incidence of adverse events during the 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: NCT00057226

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Locations

United States, California
GSK Investigational Site
San Diego, California, United States, 92108
GSK Investigational Site
Cerritos, California, United States, 90703
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20037
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32216
GSK Investigational Site
Tampa, Florida, United States, 33613
GSK Investigational Site
Boynton Beach, Florida, United States, 33437
United States, Georgia
GSK Investigational Site
Marietta, Georgia, United States, 30060
United States, Illinois
GSK Investigational Site
Libertyville, Illinois, United States, 60048
GSK Investigational Site
Oakbrook Terrace, Illinois, United States, 60181
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
GSK Investigational Site
Lafayette, Indiana, United States, 47905
United States, Louisiana
GSK Investigational Site
Shreveport, Louisiana, United States, 71101
United States, Maryland
GSK Investigational Site
Rockville, Maryland, United States, 20852
United States, Missouri
GSK Investigational Site
St. Charles, Missouri, United States, 63301
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, North Carolina
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
GSK Investigational Site
Toledo, Ohio, United States, 43623
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
GSK Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229-3815
United States, Washington
GSK Investigational Site
Bellevue, Washington, United States, 98004

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:	OHB20003
Study First Received:	March 27, 2003
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00057226 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

GW353162,
Major depressive disorder,
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 22, 2009