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A Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Bronx Veterans Medical Research Foundation, Inc.
Recruitment status was:  Recruiting
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Julia Golier, Bronx Veterans Medical Research Foundation, Inc Identifier:
First received: June 3, 2008
Last updated: September 9, 2011
Last verified: September 2011
We propose to conduct placebo-controlled trial of the glucocorticoid receptor antagonist mifepristone in Gulf War veterans (GWV) with chronic multisymptom illness (CMI) to examine its effects on physical and mental health and cognitive functioning. In addition, we propose to examine whether HPA axis biomarkers or their response to mifepristone are useful predictors of clinical response.

Condition Intervention Phase
Chronic Multisymptom Illness in Gulf War Veterans
Drug: mifepristone
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Placebo-controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness

Resource links provided by NLM:

Further study details as provided by Bronx Veterans Medical Research Foundation, Inc:

Primary Outcome Measures:
  • change in the health components score of the veterans RAND 36-item health survey (VR-36) [ Time Frame: baseline, every two weeks, endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cognitive functioning and measures of depression, fatigue and PTSD [ Time Frame: baseline and endpoint ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2008
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: mifepristone
    200 mg po per day x 6 weeks
    Drug: placebo

Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Veteran of the 1991 Gulf War
  • Veteran meets criteria for multisymptom illness

Exclusion Criteria:

  • Veteran lacks the capacity to provide consent.
  • Veteran has a major medical or neurological disorder or traumatic brain injury
  • Veteran has morning plasma cortisol level less than 5 mcg/dl or a history of adrenal insufficiency
  • Veteran is taking oral corticosteroids
  • Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder
  • Veteran has been psychiatrically hospitalized or attempted suicide within the previous 2 years
  • Veteran has current suicidal ideation
  • Veteran is pregnant or breastfeeding or plans to become pregnant within the year (male or female) not willing to use appropriate forms of contraception during the study and for at least 90 days post treatment.
  • Women veterans with diseases of the uterus by history or a family history of uterine cancer
  • Known allergy to mifepristone
  Contacts and Locations
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Please refer to this study by its identifier: NCT00691067

United States, New York
James J Peters VA Medical Center
Bronx, New York, United States, 10468
Sponsors and Collaborators
Bronx Veterans Medical Research Foundation, Inc
U.S. Army Medical Research and Materiel Command
Principal Investigator: Julia A Golier, M.D. James J Peters VA Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Julia Golier, Clinical Director, Mental Health Patient Care Center, Bronx Veterans Medical Research Foundation, Inc Identifier: NCT00691067     History of Changes
Other Study ID Numbers: GW060048 
Study First Received: June 3, 2008
Last Updated: September 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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 processed this record on January 17, 2017