Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

Posttraumatic Stress Disorder Clinical Trial

Official title:

Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00833339
• Other study ID #: 3293-08-015
• Status: Recruiting
• Phase: Phase 2
• First received: January 30, 2009
• Last updated: March 30, 2015
• Start date: May 2008
• Est. completion date: October 2015

Study information

• Verified date: March 2015
• Source: James J. Peters Veterans Affairs Medical Center
• Contact: Julia A. Golier, M.D.
• Phone: 718-584-9000
• Email: julia.golier[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• mifepristone
600 mg/day x 1 week
• placebo
placebo

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
James J. Peters Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on the total severity of the CAPS-2 and dichotomously defined clinical responder status.		baseline, endpoint, 4 week follow-up	No
Secondary	Change in cognitive functioning as measured by the MATRICS neuropsychological test battery and self-reported measures of depression and PTSD.		baseline, endpoint, 4 week follow-up	No