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

Bronx Veterans Medical Research Foundation, Inc65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Multisymptom Illness in Gulf War Veterans

Interventions

mifepristoneDRUG

200 mg po per day x 6 weeks

PlacebosDRUG

placebo

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

James J Peters VA Medical Center

The Bronx, New York, United States

Outcomes

Primary Outcomes

change in the health components score of the veterans RAND 36-item health survey (VR-36)

Time frame: baseline, every two weeks, endpoint

Secondary Outcomes

cognitive functioning and measures of depression, fatigue and PTSD

Time frame: baseline and endpoint

Data from ClinicalTrials.gov

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