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

Pending

Available Documentation

Pending

Dates Data are Available

Pending

Access Criteria

Pending

Study Characteristics

Objectives

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

All

Population

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

Intervention 

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

Time Period

November 2012 - November 2016

Setting

National

N

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

Response Rate

N/A

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

Compensation

  • $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

Contact

Tom.Sindowski@va.gov

Selected Publication

Pending

More Information

Study ClinicalTrials.gov site
ClinicalTrials.gov Identifier: NCT01739335