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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00413023

First received: August 24, 2005

Last updated: November 21, 2012

Last verified: July 2012

History of Changes

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
Depressive Disorder, Major Major Depressive Disorder (MDD)	Drug: GW679769	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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:

Change in score on a Depression rating scale following 8 weeks of treatment.

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

Intervention Details:

Other Name: GW679769

Eligibility


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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 33 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

No publications provided


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00413023 History of Changes
Other Study ID Numbers:	NKF100096
Study First Received:	August 24, 2005
Last Updated:	November 21, 2012
Health Authority:	Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Keywords provided by GlaxoSmithKline:


depression major depressive disorder MDD

Additional relevant MeSH terms:


Depression Depressive Disorder Depressive Disorder, Major Disease	Behavioral Symptoms Mental Disorders Mood Disorders Pathologic Processes

ClinicalTrials.gov processed this record on February 27, 2015

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