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Study Of GW679769 In Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00102492
First received: January 29, 2005
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy and Safety of GW679769 in Subjects With Major Depressive Disorder.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • CGI, HAM-A, QUIDS, SDS, MOS-12 Sleep Module, LSEQ, Safety and Tolerability, PK/PD

Estimated Enrollment: 348
Study Start Date: October 2004
Intervention Details:
    Drug: GW679769
    Other Name: GW679769
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102492

  Show 31 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00102492     History of Changes
Other Study ID Numbers: NKF100092
Study First Received: January 29, 2005
Last Updated: November 15, 2012
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Major Depressive Disorder
Major Depression
Mood Disorders
Major Depressive Episode

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 19, 2013