Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00413023

Purpose

The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 patients with Major depressive Disorder (MDD).

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

MedlinePlus related topics: Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate GW679769

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects With Major Depressive Disorder (MDD)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Secondary Outcome Measures:

Change in score on a number of rating scales following 8 weeks of treatment assessing symptomatic, behavioural and functional parameters which together provide a more complete description of the disorder.

Estimated Enrollment:	348
Study Start Date:	June 2005

Eligibility

Criteria

Inclusion criteria:

Primary diagnosis of Major depressive Disorder as defined in DSM-IV.
Capable of giving informed consent and willing to comply with the study requirements.
Women of childbearing potential must agree to one of a number of defined acceptable methods of birth control.

Exclusion Criteria:

Primary diagnosis within the past 6 months of another Axis 1 disorder such as an anxiety disorder.
Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type.
Subjects who, in the investigator's judgement, pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine).
Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413023

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, PhD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	NKF100096
Study First Received:	August 24, 2005
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00413023
Health Authority:	Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Keywords provided by GlaxoSmithKline:

depression
major depressive disorder
MDD

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Paroxetine
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 14, 2009