Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Drug: mifepristone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>mifepristone | Drug: mifepristone<br>* 600 mg/day x 1 week<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on the total severity of the CAPS-2 and dichotomously defined clinical responder status. |  | baseline, endpoint, 4 week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |