Status:
COMPLETED
A Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
Lead Sponsor:
Bronx Veterans Medical Research Foundation, Inc
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Chronic Multisymptom Illness in Gulf War Veterans
Eligibility:
All Genders
35+ years
Phase:
PHASE4
Brief Summary
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 physi...
Eligibility Criteria
Inclusion
- Veteran of the 1991 Gulf War
- Veteran meets criteria for multisymptom illness
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00691067
Start Date
May 1 2008
End Date
August 1 2012
Last Update
January 31 2017
Active Locations (1)
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1
James J Peters VA Medical Center
The Bronx, New York, United States, 10468