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

Major Depressive Disorder (MDD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057239
• Other study ID #: OHB20001
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2003
• Last updated: October 1, 2010
• Start date: March 2003
• Est. completion date: May 2004

Study information

• Verified date: October 2010
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 546
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder (MDD)

Intervention

Drug:
• Radafaxine

Locations

Country	Name	City	State
United States	GSK Investigational Site	Brown Deer	Wisconsin
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Clementon	New Jersey
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Conshohocken	Pennsylvania
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	Edwardsville	Illinois
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Farmington	Connecticut
United States	GSK Investigational Site	Farmington Hills	Michigan
United States	GSK Investigational Site	Glen Burnie	Maryland
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Irving	Texas
United States	GSK Investigational Site	Kenilworth	New Jersey
United States	GSK Investigational Site	Largo	Florida
United States	GSK Investigational Site	Lawrence	New York
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Maitland	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Newport Beach	California
United States	GSK Investigational Site	North Miami	Florida
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Woodstock	Vermont

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) score 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 and pain;incidence of adverse events over course of study.		8 Weeks