CCTA #0004: Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone - VA Cooperative Studies Program (CSP)
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CCTA #0004: Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone


Data Sharing Statement

What's available?


Available Documentation


Dates Data are Available


Access Criteria


Study Characteristics


To test an innovated treatment approach in post-traumatic stress disorder (PTSD) – pharmacological manipulation of the hypothalamic-pituitary-adrenal (HPA) axis, the body’s major stress system, with mifepristone

Era of Service



Male Veterans who met Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DMS-IV) criteria for PTSD, have a CAPS total score ≥50 at screening, on a stable dose of psychotropic medication for at least five weeks prior to screening (if taking) or minimum of five half-lives that elapsed prior to screening since last time of taking psychotropic medication (if not taking)

Study Design

Randomized, double-blinded, two-arm, parallel assignment clinical trial


  • Experimental comparator: Mifepristone oral tablet 
  • Placebo comparator: Placebo oral tablet 

Time Period

November 2012 - November 2016




81 (41 participants taking mifepristone, 40 participants taking placebo)

Response Rate


Recruitment Method

  • Direct contact and provider referral via phone and letter 
  • Potential participants visited with the study team to ensure inclusion and exclusion criteria were met


  • $25 for screening/medical evaluation
  • $50 per visit (total of four visits)

Data Collected

Primary outcomes

  • Percentage of clinical responders at follow-up (4 weeks) 

Secondary outcomes 

  • Percentage of clinical responders at end of study (12 weeks)
  • Change in Clinical Administered PTSD Scale (CAPS) total score from baseline, follow-up, and end of study 

Other assessments

  • Demographics
  • Changes at various points in: other CAPS scores (intrusive, avoidance, and hyperarousal symptoms), depression, PTSD symptom severity, sleep quality, anger level, plasma cortisol, and adrenocorticotropic hormone (ACTH)

Data Collection Methods 

  • In-person study visits
  • Follow-up contacts entered into an electronic data capture

Funding Source

VA Cooperative Studies Program (CSP), Cooperative Clinical Trial Award (CCTA) Program


Selected Publication


More Information

Study site Identifier: NCT01739335