Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone
Overview
- Phase
- Phase 2
- Intervention
- mifepristone
- Conditions
- Posttraumatic Stress Disorder
- Sponsor
- James J. Peters Veterans Affairs Medical Center
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change from baseline on the total severity of the CAPS-2 and dichotomously defined clinical responder status.
- Last Updated
- 11 years ago
Overview
Brief Summary
The investigators propose to conduct a randomized double-blind, parallel-group, placebo-controlled trial of mifepristone in veterans with military-related posttraumatic stress disorder (PTSD). This study will examine the clinical, neuropsychological, and neuroendocrine effects of short-term treatment of mifepristone (600 mg/day for one week) to determine if this treatment is efficacious in improving PTSD symptoms, cognitive functioning, or other related clinical measures. Additionally, the investigators will observe whether baseline neuroendocrine activity, or other clinical or neuropsychological factors predict the response to mifepristone, and whether mifepristone-induced changes in neuroendocrine activity are associated with treatment outcome.
Investigators
Julia A. Golier, M.D.
Clinical Director, Mental Health Patient Care Center
James J. Peters Veterans Affairs Medical Center
Eligibility Criteria
Inclusion Criteria
- •Subject is a male U.S. veteran
- •Subject was exposed to combat or another criterion A traumatic event during military service
- •Subject meets diagnostic criteria for chronic PTSD
Exclusion Criteria
- •Veteran has a history of adrenal insufficiency or a plasma cortisol level less than 5 mcg/dl at screening
- •Veteran has a moderate-severe traumatic brain injury, a history of a stroke, or another neurological illness or injury likely to impact cognitive functioning
- •Veteran has diabetes mellitus, an endocrinopathy, or another major medical illness.
- •Veteran is taking oral corticosteroids
- •Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
- •Veteran is currently suicidal or otherwise is in need of urgent clinical care
- •Veteran is currently receiving specialized trauma-focused psychotherapy (i.e., prolonged exposure, cognitive processing therapy or eye movement and desensitization reprocessing).
- •Veteran is not willing to use effective means of birth control during the study or for 90 days after taking study medication
- •Veteran has history of allergic reaction to mifepristone
Arms & Interventions
1
mifepristone
Intervention: mifepristone
2
Intervention: placebo
Outcomes
Primary Outcomes
Change from baseline on the total severity of the CAPS-2 and dichotomously defined clinical responder status.
Time Frame: baseline, endpoint, 4 week follow-up
Secondary Outcomes
- Change in cognitive functioning as measured by the MATRICS neuropsychological test battery and self-reported measures of depression and PTSD.(baseline, endpoint, 4 week follow-up)