Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

This study is currently recruiting participants.

Verified by James J. Peters Veterans Affairs Medical Center, January 2009

First Received: January 30, 2009 No Changes Posted

Sponsored by:	James J. Peters Veterans Affairs Medical Center
Information provided by:	James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00833339

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 II

MedlinePlus related topics: Post-Traumatic Stress Disorder

Drug Information available for: Mifepristone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone

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 Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental mifepristone	Drug: mifepristone 600 mg/day x 1 week
2: Placebo Comparator	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

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

No publications provided

Responsible Party:	James J. Peters VA Medical Center ( Julia A. Golier, M.D. )
Study ID Numbers:	3293-08-015
Study First Received:	January 30, 2009
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00833339 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Stress
Mifepristone

Contraceptives, Postcoital
Hormones
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic

Additional relevant MeSH terms:

Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Disease
Contraceptive Agents
Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Stress
Mifepristone
Reproductive Control Agents

Luteolytic Agents
Contraceptives, Postcoital
Pharmacologic Actions
Stress Disorders, Traumatic
Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Abortifacient Agents
Menstruation-Inducing Agents
Stress Disorders, Post-Traumatic
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on May 06, 2009