Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone

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.

Study Overview

• Status: Unknown
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Drug: placebo; Drug: mifepristone

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10468
      • Recruiting
      • James J. Peters VA Medical Center
      • Principal Investigator: Julia A. Golier, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2	Drug: placebo; placebo
Experimental: 1; mifepristone	Drug: mifepristone; 600 mg/day x 1 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline on the total severity of the CAPS-2 and dichotomously defined clinical responder status.	baseline, endpoint, 4 week follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: James J. Peters Veterans Affairs Medical Center
• Investigators: Principal Investigator: Julia A Golier, MD, JJP VAMC; Mount Sinai Sch of Med

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (Estimate): February 2, 2009

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Abortifacient Agents; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Mifepristone
• Other Study ID Numbers: 3293-08-015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No