Study Of GW679769 In Major Depressive Disorder

Depressive Disorder, Major Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy and Safety of GW679769 in Subjects With Major Depressive Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102492
• Other study ID #: NKF100092
• Status: Completed
• Phase: Phase 2
• First received: January 29, 2005
• Last updated: April 14, 2015
• Start date: October 2004
• Est. completion date: September 2006

Study information

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

Clinical Trial Summary

This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of GW679769 in subjects with major depressive disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion criteria:

• Subjects must have the ability to comprehend the key components of the consent form.

• Subject must have met DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria for current MDE (major depressive episode) for at least 8 weeks prior to the Screening Visit.

• If female, subjects must be practicing an acceptable method of birth control.

• Subjects must have rating scores as outlined.

Exclusion criteria:

• Subjects whose symptoms of the MDE are better accounted for by another diagnosis.

• Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.

• Subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months.

• Subjects with an unstable medical disorder.

• If female, pregnant or lactating.

• Subjects who have received ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation) within the 6 months preceding screening or who have ever been homicidal.

Related Conditions & MeSH terms

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

Intervention

Drug:
• GW679769

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Miramichi	New Brunswick
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Sherbrooke	Quebec
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Beachwood	Ohio
United States	GSK Investigational Site	Bellevue	Washington
United States	GSK Investigational Site	Beverly Hills	California
United States	GSK Investigational Site	Brooklyn	New York
United States	GSK Investigational Site	Clementon	New Jersey
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Farmington Hills	Michigan
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Irving	Texas
United States	GSK Investigational Site	Lake Jackson	Texas
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	North Miami	Florida
United States	GSK Investigational Site	Oakbrook Terrace	Illinois
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Rockville	Maryland
United States	GSK Investigational Site	Scottsdale	Arizona
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Smyrna	Georgia
United States	GSK Investigational Site	St. Charles	Missouri
United States	GSK Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D) total score at week 8, Last Observation Carried Forward.
Secondary	CGI, HAM-A, QUIDS, SDS, MOS-12 Sleep Module, LSEQ, Safety and Tolerability, PK/PD