Recruiting
Phase 2

Mifepristone

Sponsor:

James J. Peters Veterans Affairs Medical Center

Code:

NCT00833339

Conditions

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mifepristone

placebo

Study Details

Brief summary:

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.

Conditions

Posttraumatic Stress Disorder

Study ID

NCT00833339

Start date

May, 2008

Status verified date

Mar, 2015

Completion date

Oct, 2015

Anticipated

Primary completion date

Oct, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Interventions and Outcome Measures

Arms

experimental: 1

mifepristone

placebo comparator: 2

Interventions

mifepristone

600 mg/day x 1 week

placebo

placebo

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 ]

Central Contacts and Locations

Central contacts

Julia A. Golier, M.D.

718-584-9000julia.golier@va.gov

Locations

James J. Peters VA Medical Center

Recruiting

Bronx, New York, United States, 10468

Principal Investigator:

Julia A. Golier, M.D.

More Information

Sponsor

James J. Peters Veterans Affairs Medical Center

Last update posted

Apr 1, 2015

Last verified

Mar, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by James J. Peters Veterans Affairs Medical Center on 2015-04-01.