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

 

Investigator Access

What's Available

 

 

Check with study contact or publications for information on a public dataset, data archive, data enclave, or website where data might be available.

Available Documentation

Dates Data are Available

Access Criteria

Investigators associated with VA or non-VA nonprofit, academic, or research institutions may submit a Research Resource Request form to Tom.Sindowski@va.gov. Investigators may be asked to provide further documentation such as a study proposal. All requests are reviewed for scientific and ethical merit. Access is contingent upon approval by the requestor’s Institutional Review Board (IRB) and, if applicable, a VA Research and Development (R&D) Committee. To gain access, requestors must sign a VA data use agreement. Requestors must be fully compliant with VA data security, privacy, and human subjects requirements.

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

Interventions 

  • 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

Unconfirmed

Recruitment Method

Participants were recruited through direct contact and provider referral. Contact methods approved by governing IRB included phone and letter with pre-established oral and written scripts. Patients agreeing to be evaluated had initial visit with the study team that again ensured inclusion and exclusion criteria are met. Participants are then asked to sign a written consent.

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 Sources

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

Investigators

Julia A Golier, MD

Contact

Tom.Sindowski@va.gov

Selected Publications

Check with study contact

More Information

  • Study ClinicalTrials.gov site
  • ClinicalTrials.gov Identifier: NCT01739335
  • Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)