Study Of GW679769 In Major Depressive Disorder

NCT ID: NCT00102492

Last Updated: 2015-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-09-30

Brief Summary

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

Detailed Description

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Conditions

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Depressive Disorder, Major Major Depressive Disorder (MDD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW679769

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Scottsdale, Arizona, United States

Site Status

GSK Investigational Site

Little Rock, Arkansas, United States

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Beverly Hills, California, United States

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Fort Lauderdale, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Winter Park, Florida, United States

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Marietta, Georgia, United States

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Smyrna, Georgia, United States

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Oakbrook Terrace, Illinois, United States

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Shreveport, Louisiana, United States

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Rockville, Maryland, United States

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Farmington Hills, Michigan, United States

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Saint Charles, Missouri, United States

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Clementon, New Jersey, United States

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Brooklyn, New York, United States

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New York, New York, United States

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New York, New York, United States

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Beachwood, Ohio, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Irving, Texas, United States

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Lake Jackson, Texas, United States

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Bellevue, Washington, United States

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Edmonton, Alberta, Canada

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Miramichi, New Brunswick, Canada

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Mississauga, Ontario, Canada

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Sherbrooke, Quebec, Canada

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Countries

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United States Canada

Other Identifiers

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NKF100092

Identifier Type: -

Identifier Source: org_study_id

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