Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

NCT ID: NCT00833339

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2015-10-31

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

1

mifepristone

Group Type: EXPERIMENTAL

mifepristone

Intervention Type: DRUG

600 mg/day x 1 week

2

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

Interventions

mifepristone

600 mg/day x 1 week

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

James J. Peters Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Julia A. Golier, M.D.

Clinical Director, Mental Health Patient Care Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julia A Golier, MD

Role: PRINCIPAL_INVESTIGATOR

JJP VAMC; Mount Sinai Sch of Med

Locations

James J. Peters VA Medical Center

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Julia A. Golier, M.D.

Role: CONTACT

julia.golier@va.gov

718-584-9000 ext. 5196

Other Identifiers

3293-08-015

Identifier Type: -

Identifier Source: org_study_id