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

Bronx Veterans Medical Research Foundation, Inc

Status and phase

Completed

Phase 4

Conditions

Chronic Multisymptom Illness in Gulf War Veterans

Treatments

Drug: mifepristone

Drug: Placebos

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00691067

GW060048

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

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