Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder
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ClinicalTrials.gov Identifier: NCT00833339 |
Recruitment Status
: Unknown
Verified March 2015 by Julia A. Golier, M.D., James J. Peters Veterans Affairs Medical Center.
Recruitment status was: Recruiting
First Posted
: February 2, 2009
Last Update Posted
: April 1, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Posttraumatic Stress Disorder | Drug: mifepristone Drug: placebo | Phase 2 |
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 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833339
Contact: Julia A. Golier, M.D. | 718-584-9000 ext 5196 | julia.golier@va.gov |
United States, New York | |
James J. Peters VA Medical Center | Recruiting |
Bronx, New York, United States, 10468 | |
Principal Investigator: Julia A. Golier, M.D. |
Principal Investigator: | Julia A Golier, MD | JJP VAMC; Mount Sinai Sch of Med |
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 Key Record Dates |
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 |