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Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

This study is ongoing, but not recruiting participants.
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: August 16, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Posttraumatic Stress Disorder
 Drug: mifepristone
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by James J. Peters Veterans Affairs Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: May 2008
Estimated Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
mifepristone
 Drug: mifepristone
600 mg/day x 1 week
Placebo Comparator: 2 Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833339

Locations
United States, New York
James J. Peters VA Medical Center
Bronx, New York, United States, 10468
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Investigators
Principal Investigator: Julia A Golier, MD JJP VAMC; Mount Sinai Sch of Med
  More Information

No publications provided

Responsible Party: Julia A. Golier, M.D., Clinical Director, Mental Health Patient Care Center, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00833339     History of Changes
Other Study ID Numbers: 3293-08-015
Study First Received: January 30, 2009
Last Updated: August 16, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Mifepristone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 16, 2013