Clinical trial NCT00102492: Study Of GW679769 In Major Depressive Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder, Major
Major Depressive Disorder (MDD)
Keywords: Major Depressive Disorder
Major Depression
Mood Disorders
Major Depressive Episode
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-01-31
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Change from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D) total score at week 8, Last Observation Carried Forward.
Secondary outcomes:
measure: CGI, HAM-A, QUIDS, SDS, MOS-12 Sleep Module, LSEQ, Safety and Tolerability, PK/PD
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: GSK Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: North Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Winter Park
country: United States
facility: GSK Investigational Site
state: Florida
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Smyrna
country: United States
facility: GSK Investigational Site
state: Georgia
city: Oakbrook Terrace
country: United States
facility: GSK Investigational Site
state: Illinois
city: Shreveport
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Rockville
country: United States
facility: GSK Investigational Site
state: Maryland
city: Farmington Hills
country: United States
facility: GSK Investigational Site
state: Michigan
city: St. Charles
country: United States
facility: GSK Investigational Site
state: Missouri
city: Clementon
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Beachwood
country: United States
facility: GSK Investigational Site
state: Ohio
city: Eugene
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Irving
country: United States
facility: GSK Investigational Site
state: Texas
city: Lake Jackson
country: United States
facility: GSK Investigational Site
state: Texas
city: Bellevue
country: United States
facility: GSK Investigational Site
state: Washington
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Miramichi
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: