Study Of GW679769 In Major Depressive Disorder

April 14, 2015 updated by: GlaxoSmithKline

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy and Safety of GW679769 in Subjects With Major Depressive Disorder.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6L 5X8
        • GSK Investigational Site
    • New Brunswick
      • Miramichi, New Brunswick, Canada, E1V 3G5
        • GSK Investigational Site
    • Ontario
      • Mississauga, Ontario, Canada, L5M 4N4
        • GSK Investigational Site
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 4J6
        • GSK Investigational Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72223
        • GSK Investigational Site
    • California
      • Beverly Hills, California, United States, 90210
        • GSK Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33301
        • GSK Investigational Site
      • Miami, Florida, United States, 33125
        • GSK Investigational Site
      • North Miami, Florida, United States, 33161
        • GSK Investigational Site
      • Orlando, Florida, United States, 32806
        • GSK Investigational Site
      • Winter Park, Florida, United States, 32789
        • GSK Investigational Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • GSK Investigational Site
      • Smyrna, Georgia, United States, 30080
        • GSK Investigational Site
    • Illinois
      • Oakbrook Terrace, Illinois, United States, 60181
        • GSK Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71104
        • GSK Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • GSK Investigational Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • GSK Investigational Site
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • GSK Investigational Site
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • GSK Investigational Site
    • New York
      • Brooklyn, New York, United States, 11235
        • GSK Investigational Site
      • New York, New York, United States, 10021
        • GSK Investigational Site
      • New York, New York, United States, 10024
        • GSK Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
      • Portland, Oregon, United States, 97209
        • GSK Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • GSK Investigational Site
      • Irving, Texas, United States, 75039
        • GSK Investigational Site
      • Lake Jackson, Texas, United States, 77566
        • GSK Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D) total score at week 8, Last Observation Carried Forward.

Secondary Outcome Measures

Outcome Measure
CGI, HAM-A, QUIDS, SDS, MOS-12 Sleep Module, LSEQ, Safety and Tolerability, PK/PD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

January 29, 2005

First Submitted That Met QC Criteria

January 28, 2005

First Posted (Estimate)

January 31, 2005

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKF100092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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