Trial record 47 of 1941 for:    major | "Depressive Disorder, Major"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00057213
Recruitment Status : Completed
First Posted : March 28, 2003
Last Update Posted : April 16, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Radafaxine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 367 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : March 2003
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. 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;

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00057213

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
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00057213     History of Changes
Other Study ID Numbers: OHB20002
First Posted: March 28, 2003    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015

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

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