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

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

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Drug: Radafaxine

• Study Type: Interventional
• Enrollment: 546
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score after 8 weeks of treatment	8 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	8 Weeks

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, M.D., GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): May 1, 2004
• Study Completion (Actual): May 1, 2004

Study Registration Dates

• First Submitted: March 27, 2003
• First Submitted That Met QC Criteria: March 27, 2003
• First Posted (Estimate): March 28, 2003

Study Record Updates

• Last Update Posted (Estimate): October 4, 2010
• Last Update Submitted That Met QC Criteria: October 1, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: MDD; Major Depressive Disorder; GW353162
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major
• Other Study ID Numbers: OHB20001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No