Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by James J. Peters Veterans Affairs Medical Center
Sponsor:
Information provided by (Responsible Party):
Julia A. Golier, M.D., James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00833339
First received: January 30, 2009
Last updated: March 30, 2015
Last verified: March 2015

January 30, 2009
March 30, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Recruiting
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
Male
18 Years and older
No
Contact: Julia A. Golier, M.D. 718-584-9000 ext 5196 julia.golier@va.gov
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