Status:
UNKNOWN
Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder
Lead Sponsor:
James J. Peters Veterans Affairs Medical Center
Conditions:
Posttraumatic Stress Disorder
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 st...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2015
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00833339
Start Date
May 1 2008
End Date
October 1 2015
Last Update
April 1 2015
Active Locations (1)
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1
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468