Study Of GW679769 In Major Depressive Disorder
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy and Safety of GW679769 in Subjects With Major Depressive Disorder.
1 other identifier
interventional
356
2 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2004
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 29, 2005
CompletedFirst Posted
Study publicly available on registry
January 31, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedApril 16, 2015
April 1, 2015
1.9 years
January 29, 2005
April 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D) total score at week 8, Last Observation Carried Forward.
Secondary Outcomes (1)
CGI, HAM-A, QUIDS, SDS, MOS-12 Sleep Module, LSEQ, Safety and Tolerability, PK/PD
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (31)
GSK Investigational Site
Scottsdale, Arizona, 85251, United States
GSK Investigational Site
Little Rock, Arkansas, 72223, United States
GSK Investigational Site
Beverly Hills, California, 90210, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33301, United States
GSK Investigational Site
Miami, Florida, 33125, United States
GSK Investigational Site
North Miami, Florida, 33161, United States
GSK Investigational Site
Orlando, Florida, 32806, United States
GSK Investigational Site
Winter Park, Florida, 32789, United States
GSK Investigational Site
Marietta, Georgia, 30060, United States
GSK Investigational Site
Smyrna, Georgia, 30080, United States
GSK Investigational Site
Oakbrook Terrace, Illinois, 60181, United States
GSK Investigational Site
Shreveport, Louisiana, 71104, United States
GSK Investigational Site
Rockville, Maryland, 20852, United States
GSK Investigational Site
Farmington Hills, Michigan, 48336, United States
GSK Investigational Site
Saint Charles, Missouri, 63301, United States
GSK Investigational Site
Clementon, New Jersey, 08021, United States
GSK Investigational Site
Brooklyn, New York, 11235, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
New York, New York, 10024, United States
GSK Investigational Site
Beachwood, Ohio, 44122, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Portland, Oregon, 97209, United States
GSK Investigational Site
Memphis, Tennessee, 38119, United States
GSK Investigational Site
Austin, Texas, 78756, United States
GSK Investigational Site
Irving, Texas, 75039, United States
GSK Investigational Site
Lake Jackson, Texas, 77566, United States
GSK Investigational Site
Bellevue, Washington, 98004, United States
GSK Investigational Site
Edmonton, Alberta, T6L 5X8, Canada
GSK Investigational Site
Miramichi, New Brunswick, E1V 3G5, Canada
GSK Investigational Site
Mississauga, Ontario, L5M 4N4, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 4J6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2005
First Posted
January 31, 2005
Study Start
October 1, 2004
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
April 16, 2015
Record last verified: 2015-04