Evaluation of GSK561679 in Women With Post-Traumatic Stress Disorder
|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|
- Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. The severity of symptoms is rated on a scale from 0-4, where, 0 = Absent, 1 = Mild/subthreshold; 2 = Moderate/ threshold, 3 = Severe/markedly elevated and 4 = Extreme/ incapacitating. Scores may range from 0 (no symptoms) to 136 (severe symptoms). Change is the difference in scores between baseline and 6 weeks.
- Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]The number of participants that showed at least a 50% reduction in CAPS scores from their baseline visit at the end of 6 weeks were measured has having a response to the treatment. The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms).
- Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]The MADRS is a ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with depressive disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Change is the difference in scores between baseline and 6 weeks.
- Safety, Measured by the Number of Subjects That Experienced an Adverse Event [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]The occurrence of adverse events will be recorded at the end of 6 weeks.
|Study Start Date:||December 2009|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Adult women with DSM-IV defined PTSD will receive matching placebo for 6 weeks
Matching placebo, oral administration, 1 pill/day for 6 weeks
Other Name: Sugar Pill
Adult women with DSM-IV-defined PTSD will receive GSK561679 at a fixed dose of 350 mg/day for 6-weeks
GSK561679, oral administration, 350mg/day, 6 week administration
Other Name: CRF1 antagonist
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.
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.
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|