Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder
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ClinicalTrials.gov Identifier: NCT00833339
Recruitment Status : Unknown
Verified March 2015 by Julia A. Golier, M.D., James J. Peters Veterans Affairs Medical Center. Recruitment status was: Recruiting
First Posted : February 2, 2009
Last Update Posted : April 1, 2015
James J. Peters Veterans Affairs Medical Center
Information provided by (Responsible Party):
Julia A. Golier, M.D., James J. Peters Veterans Affairs Medical Center
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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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