Evaluation of GSK561679 in Women With Post-Traumatic Stress Disorder
Post-traumatic stress disorder (PTSD) is a chronic and common anxiety disorder that follows exposure to an overwhelming traumatic event. The majority of patients with PTSD also meet criteria for other psychiatric disorders and PTSD is associated with an increased risk for suicide attempts.
PTSD is responsive to psychological and pharmacological treatments, such as selective serotonin reuptake inhibitors (SSRIs), but response rates rarely exceed 60%, and even fewer patients (20-30%) achieve clinical remission. Thus, there is a clear need to develop novel and improved therapeutics for PTSD.
This study will test the hypothesis of whether an antagonist at the corticotropin releasing factor type 1 receptor (i.e. GSK561679) is superior to placebo in reducing symptoms of PTSD. The study is being conducted at 2 sites in the United States: a site at Emory University, and one at Mount Sinai School of Medicine. About 150 women outpatients aged 21 to 65 who currently suffer from PTSD will be enrolled. Study participation could last for up to about 12 weeks.
The study is divided into 4 phases:
Phase 1 (Screening): a 1 week no drug screening period to assess study eligibility.
Phase 2 (Pre-Treatment Testing Period): Eligible patients will be enrolled into a 1 week Testing Phase, which will include neuropsychological and neurophysiological testing as well as blood draws and electrocardiogram.
Phase 3 (Treatment Period): Eligible patients will be enrolled in a two-armed 6-week period of double-blind placebo-controlled acute treatment. All subjects who continue to meet eligibility criteria will be randomized to one of two groups: GSK561679 (at a fixed dose of 350 mg/day) or placebo. Randomization will be performed at a 1:1 ratio into two treatment groups. Neuropsychological and neurophysiological testing will be repeated after 5 weeks of the double-blind treatment period.
Phase 4 (Follow-up Period): Safety follow-up visits will be conducted 1 week and 1 month after the end of the treatment Phase 3.
Primary efficacy outcome measure for the study will be the Clinician-Administered PTSD scale (CAPS).
Secondary efficacy outcome measure will include the Montgomery-Asberg Depression Rating Scale (MADRS).
Safety measures will include adverse event recording at every visit, clinical laboratory measures, vital sign parameters, electrocardiograms (ECGs), and physical examinations.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
|Official Title:||Evaluation of the Efficacy of the CRF1 Antagonist GSK561679 in Women With Post-traumatic Stress Disorder|
- CAPS score after 6 weeks treatment [ Time Frame: 6 weeks active treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
placebo compound for 6 weeks
placebo compound treatment for comparison with IP
Other Name: sugar pill/placebo
Active Comparator: GSK561679
GSK561679, oral administration, 350mg/day, 6 week administration
Other Name: CRF1 antagonist
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018992
|United States, California|
|Stress and Health Research Program, San Francisco VA Medical Center, University of California San Francisco|
|San Francisco, California, United States, 94121|
|United States, Georgia|
|Atlanta, Georgia, United States, 30306|
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Boadie Dunlop, MD||Emory University|