Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Posttraumatic Stress Disorder	Drug: mifepristone; Drug: placebo	Phase 2

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Official Title:	Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone
Study Start Date :	May 2008
Estimated Primary Completion Date :	October 2015
Estimated Study Completion Date :	October 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Julia A. Golier, M.D.	718-584-9000 ext 5196	julia.golier@va.gov

Locations

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

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	February 2, 2009
Last Update Posted:	April 1, 2015
Last Verified:	March 2015

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Mifepristone; Abortifacient Agents, Steroidal; Abortifacient Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptives, Oral, Synthetic	Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Luteolytic Agents; Menstruation-Inducing Agents