Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

This study is ongoing, but not recruiting participants.

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: August 16, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 30, 2009

Last Updated Date

August 16, 2012

Start Date ^ICMJE

May 2008

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00833339 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

Official Title ^ICMJE

Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Posttraumatic Stress Disorder

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
mifepristone

Intervention: Drug: mifepristone
Placebo Comparator: 2
Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2012

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00833339

Other Study ID Numbers ^ICMJE

3293-08-015

Has Data Monitoring Committee

Yes

Responsible Party

Julia A. Golier, M.D., James J. Peters Veterans Affairs Medical Center

Study Sponsor ^ICMJE

James J. Peters Veterans Affairs Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Julia A Golier, MD

JJP VAMC; Mount Sinai Sch of Med

Information Provided By

James J. Peters Veterans Affairs Medical Center

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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