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An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00057213
First received: March 27, 2003
Last updated: April 11, 2013
Last verified: March 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Depressive Disorder, Major
 Drug: Radafaxine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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
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
Intervention Details:
    Drug: Radafaxine
    Other Name: Radafaxine
  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
Garden Grove, California, United States, 92845
GSK Investigational Site
Irvine, California, United States, 92618
GSK Investigational Site
National City, California, United States, 91950
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
Chapel Hill, North Carolina, United States, 27514
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
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 GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00057213     History of Changes
Other Study ID Numbers: OHB20002
Study First Received: March 27, 2003
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Major Depressive Disorder (MDD),
Flexible
GW353162,

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 21, 2013