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

Depressive Disorder, Major Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057213
• Other study ID #: OHB20002
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2003
• Last updated: April 15, 2015
• Start date: March 2003
• Est. completion date: April 2007

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

Drug:
• Radafaxine

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Brockton	Massachusetts
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Florence	Kentucky
United States	GSK Investigational Site	Galveston	Texas
United States	GSK Investigational Site	Garden Grove	California
United States	GSK Investigational Site	Irvine	California
United States	GSK Investigational Site	Lake Jackson	Texas
United States	GSK Investigational Site	Lyndhurst	Ohio
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	National City	California
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Peoria	Arizona
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Scottsdale	Arizona
United States	GSK Investigational Site	Springfield	Illinois
United States	GSK Investigational Site	Terre Haute	Indiana
United States	GSK Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks of treatment		8 Weeks
Secondary	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;