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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
Sponsor:
Information provided by (Responsible Party):
Julia A. Golier, M.D., James J. Peters Veterans Affairs Medical Center

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 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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
mifepristone
Drug: mifepristone
600 mg/day x 1 week

Placebo Comparator: 2 Drug: placebo
placebo




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 ]


Information from the National Library of Medicine

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

Information from the National Library of Medicine

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


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

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