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Status:

COMPLETED

Study Of GW679769 In Major Depressive Disorder

Lead Sponsor:

GlaxoSmithKline

Conditions:

Depressive Disorder, Major

Major Depressive Disorder (MDD)

Eligibility:

All Genders

18-64 years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    October 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2006

    Estimated Enrollment :

    356 Patients enrolled

    Trial Details

    Trial ID

    NCT00102492

    Start Date

    October 1 2004

    End Date

    September 1 2006

    Last Update

    April 16 2015

    Active Locations (31)

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    Page 1 of 8 (31 locations)

    1

    GSK Investigational Site

    Scottsdale, Arizona, United States, 85251

    2

    GSK Investigational Site

    Little Rock, Arkansas, United States, 72223

    3

    GSK Investigational Site

    Beverly Hills, California, United States, 90210

    4

    GSK Investigational Site

    Fort Lauderdale, Florida, United States, 33301