Study Of GW679769 In Major Depressive Disorder - Full Text View

Purpose

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

Condition	Intervention	Phase
Major Depressive Disorder (MDD)	Drug: GW679769	Phase II

MedlinePlus related topics:

Depression

ChemIDplus related topics:

GW679769

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D) total score at week 8, Last Observation Carried Forward.

Secondary Outcome Measures:

CGI, HAM-A, QUIDS, SDS, MOS-12 Sleep Module, LSEQ, Safety and Tolerability, PK/PD

Estimated Enrollment:	348
Study Start Date:	October 2004

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102492

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD, MS	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	NKF100092
First Received:	January 29, 2005
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00102492
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada