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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bronx Veterans Medical Research Foundation, Inc
• Collaborators: U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Treatments: Mifepristone

Criteria

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