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Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Julia A. Golier, M.D., James J. Peters Veterans Affairs Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00833339
First Posted: February 2, 2009
Last Update Posted: April 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Julia A. Golier, M.D., James J. Peters Veterans Affairs Medical Center
January 30, 2009
February 2, 2009
April 1, 2015
May 2008
October 2015   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00833339 on ClinicalTrials.gov Archive Site
Change in cognitive functioning as measured by the MATRICS neuropsychological test battery and self-reported measures of depression and PTSD. [ Time Frame: baseline, endpoint, 4 week follow-up ]
Same as current
Not Provided
Not Provided
 
Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder
Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Posttraumatic Stress Disorder
  • Drug: mifepristone
    600 mg/day x 1 week
  • Drug: placebo
    placebo
  • Experimental: 1
    mifepristone
    Intervention: Drug: mifepristone
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
October 2015
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00833339
3293-08-015
Yes
Not Provided
Not Provided
Julia A. Golier, M.D., James J. Peters Veterans Affairs Medical Center
James J. Peters Veterans Affairs Medical Center
Not Provided
Principal Investigator: Julia A Golier, MD JJP VAMC; Mount Sinai Sch of Med
James J. Peters Veterans Affairs Medical Center
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP