Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

This study is currently recruiting participants. (see Contacts and Locations)

Verified March 2015 by James J. Peters Veterans Affairs Medical Center

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: March 30, 2015

Last verified: March 2015

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:

MedlinePlus related topics: Post-Traumatic Stress Disorder

Drug Information available for: Mifepristone

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 2015
Estimated Primary Completion Date:	October 2015 (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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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


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:	March 30, 2015
Health Authority:	United States: Federal Government

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

ClinicalTrials.gov processed this record on September 26, 2016

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