An 8 Week Study Of Adults Diagnosed With Major Depressive Disorder

This study has been completed.

First Received: March 27, 2003 Last Updated: May 15, 2009 History of Changes

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

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

Criteria

Inclusion Criteria:

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

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 05, 2009