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

Completed · Phase 2

Conditions studied: Major Depressive Disorder (MDD)

In brief

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

Key facts

Study ID

NCT00057239

Run by

GlaxoSmithKline

People needed

546

Starts

2003-03-01

Expected to finish

2004-05-01

Last updated by the study team

2010-10-04

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — Farmington, Connecticut, United States
• GSK Investigational Site — Largo, Florida, United States
• GSK Investigational Site — Maitland, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — North Miami, Florida, United States
• GSK Investigational Site — Edwardsville, Illinois, United States
• GSK Investigational Site — Glen Burnie, Maryland, United States
• GSK Investigational Site — Farmington Hills, Michigan, United States
• GSK Investigational Site — Minneapolis, Minnesota, United States
• GSK Investigational Site — Clementon, New Jersey, United States
• GSK Investigational Site — Kenilworth, New Jersey, United States
• GSK Investigational Site — Lawrence, New York, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Dayton, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Eugene, Oregon, United States
• GSK Investigational Site — Portland, Oregon, United States
• GSK Investigational Site — Portland, Oregon, United States
• GSK Investigational Site — Conshohocken, Pennsylvania, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Irving, Texas, United States

Full record on ClinicalTrials.gov

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