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

This study is currently recruiting participants.

Verified by GlaxoSmithKline, April 2009

First Received: August 12, 2008 Last Updated: April 23, 2009 History of Changes

Sponsored by:	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
Major Depressive Disorder (MDD)	Drug: GSK561679 or placebo daily for 6 weeks	Phase II

MedlinePlus related topics: Depression

U.S. FDA Resources

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change in score on a depression rating scale following 6 weeks of treatment.

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.

Estimated Enrollment:	150
Study Start Date:	October 2008

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 22 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106139
Study First Received:	August 12, 2008
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00733980 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Major depressive disorder

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Antidepressive Agents
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease
Depression
Mental Disorders

Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 07, 2009