An 8 Week Study Of 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 (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: NCT00057226
• Other study ID #: OHB20003
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2003
• Last updated: April 15, 2015
• Start date: March 2003
• Est. completion date: April 2004

Study information

• Verified date: April 2015
• 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 Medication in Patients with Major Depressive Disorder (MDD)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: April 2004
• Est. primary completion date: April 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

Intervention

Drug:
• Radafaxine

Locations

Country	Name	City	State
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Bellevue	Washington
United States	GSK Investigational Site	Boynton Beach	Florida
United States	GSK Investigational Site	Cerritos	California
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Lafayette	Indiana
United States	GSK Investigational Site	Libertyville	Illinois
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Oakbrook Terrace	Illinois
United States	GSK Investigational Site	Rockville	Maryland
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	St. Charles	Missouri
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Winston-Salem	North Carolina

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 the Global Impression; percentage of remitters and responders based on the MADRS; change in anxiety, disability, motivation, energy, fatigue and pain; incidence of adverse events during the study