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Study Of GW679769 In Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00102492
Recruitment Status : Completed
First Posted : January 31, 2005
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Major Depressive Disorder (MDD) Drug: GW679769 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : October 2004
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 :
  1. CGI, HAM-A, QUIDS, SDS, MOS-12 Sleep Module, LSEQ, Safety and Tolerability, PK/PD


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102492


Locations
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United States, Arizona
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72223
United States, California
GSK Investigational Site
Beverly Hills, California, United States, 90210
United States, Florida
GSK Investigational Site
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
United States, Georgia
GSK Investigational Site
Marietta, Georgia, United States, 30060
GSK Investigational Site
Smyrna, Georgia, United States, 30080
United States, Illinois
GSK Investigational Site
Oakbrook Terrace, Illinois, United States, 60181
United States, Louisiana
GSK Investigational Site
Shreveport, Louisiana, United States, 71104
United States, Maryland
GSK Investigational Site
Rockville, Maryland, United States, 20852
United States, Michigan
GSK Investigational Site
Farmington Hills, Michigan, United States, 48336
United States, Missouri
GSK Investigational Site
St. Charles, Missouri, United States, 63301
United States, New Jersey
GSK Investigational Site
Clementon, New Jersey, United States, 08021
United States, New York
GSK Investigational Site
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
United States, Ohio
GSK Investigational Site
Beachwood, Ohio, United States, 44122
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
GSK Investigational Site
Portland, Oregon, United States, 97209
United States, Tennessee
GSK Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78756
GSK Investigational Site
Irving, Texas, United States, 75039
GSK Investigational Site
Lake Jackson, Texas, United States, 77566
United States, Washington
GSK Investigational Site
Bellevue, Washington, United States, 98004
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T6L 5X8
Canada, New Brunswick
GSK Investigational Site
Miramichi, New Brunswick, Canada, E1V 3G5
Canada, Ontario
GSK Investigational Site
Mississauga, Ontario, Canada, L5M 4N4
Canada, Quebec
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 4J6
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00102492    
Other Study ID Numbers: NKF100092
First Posted: January 31, 2005    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015
Keywords provided by GlaxoSmithKline:
Major Depressive Disorder
Major Depression
Mood Disorders
Major Depressive Episode
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Casopitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action