Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

NCT00833339 | Unknown Phase 2 DMC

• 1 other identifier: 3293-08-015
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline on the total severity of the CAPS-2 and dichotomously defined clinical responder status.

  baseline, endpoint, 4 week follow-up

Secondary Outcomes (1)

• Change in cognitive functioning as measured by the MATRICS neuropsychological test battery and self-reported measures of depression and PTSD.

  baseline, endpoint, 4 week follow-up

Study Arms (2)

1

EXPERIMENTAL

mifepristone

Drug: mifepristone

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

mifepristone DRUG

600 mg/day x 1 week

1

placebo DRUG

placebo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Julia A Golier, MD

  JJP VAMC; Mount Sinai Sch of Med

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia A. Golier, M.D.

CONTACT

718-584-9000; julia.golier@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, Mental Health Patient Care Center

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 2, 2009
• Study Start: May 1, 2008
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

US (1)