A Study of the Effects of a New Antidepressant Treatment (GSK561679) in Females With Major Depressive Disorder - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00733980

Purpose

This six-week study will evaluate the efficacy, safety and tolerability of GSK561679 compared to placebo in female subjects with major depressive disorder

Condition	Intervention	Phase
Depressive Disorder, Major Major Depressive Disorder (MDD)	Drug: GSK561679 Other: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Six-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of GSK561679 Compared to Placebo in Female Subjects, Diagnosed With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change in score on a depression rating scale following 6 weeks of treatment. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Endpoints related to changes in anxiety, sleep &stress throughout the treatment period,safety and tolerability including adverse events, vital signs, clinical laboratory values & ECGs throughtout the study & discontinuation symptoms during follow up. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	October 2008
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GSK561679 arm	Drug: GSK561679 GSK561679 or placebo daily for 6 weeks Other Name: GSK561679 or placebo daily for 6 weeks Other: Placebo Placebo
Placebo Comparator: placebo arm	Other: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion:

Major depressive episode associated with Major Depressive Disorder (DSM-IV-TR criteria)

Duration of current episode is at least 4 weeks duration
Subjects who agree to use acceptable methods of birth control throughout the study

Key Exclusion:

Subjects with a diagnosis or history of dementia, schizophrenia, bipolar disorder, borderline personality disorder, anorexia, bulimia, suicide attempts or suicidal behavior will not be eligible to participate.
Subjects who have significant lab abnormalities or unstable medical conditions
Subject has initiated psychotherapy within one month prior to the Screening visit
Received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening
Failed to respond to an adequate course of pharmacotherapy of at least 2 different classes of antidepressants
Positive urine drug screen or positive blood alcohol
Pregnant or nursing
Received psychoactive drugs (except sleep aids) within 1 week of screening visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733980

Locations

United States, California
GSK Investigational Site
Cerritos, California, United States, 90703
GSK Investigational Site
San Diego, California, United States, 92108
GSK Investigational Site
Torrance, California, United States, 90502
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32216
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30322
GSK Investigational Site
Marietta, Georgia, United States, 30060
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
Skokie, Illinois, United States, 60076
United States, Louisiana
GSK Investigational Site
Shreveport, Louisiana, United States, 71104
United States, Maryland
GSK Investigational Site
Rockville, Maryland, United States, 20852
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87109
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45219-0516
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
GSK Investigational Site
Memphis, Tennessee, United States, 38119
United States, Wisconsin
GSK Investigational Site
Brown Deer, Wisconsin, United States, 53223
GSK Investigational Site
Madison, Wisconsin, United States, 53719

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00733980 History of Changes
Other Study ID Numbers:	106139
Study First Received:	August 12, 2008
Last Updated:	May 5, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Major depressive disorder

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012