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

Phase 4

Completed

• Conditions: Chronic Multisymptom Illness in Gulf War Veterans
• Interventions: Drug: mifepristone; Drug: Placebos

• Registration Number: NCT00691067
• Lead Sponsor: Bronx Veterans Medical Research Foundation, Inc

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-05
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mifepristone	mifepristone	600mg of Mifepristone
Placebos	Placebos	Placebo

Primary Outcome Measures

Name	Time	Method
change in the health components score of the veterans RAND 36-item health survey (VR-36)	baseline, every two weeks, endpoint

Secondary Outcome Measures

Name	Time	Method
cognitive functioning and measures of depression, fatigue and PTSD	baseline and endpoint

Trial Locations

Locations (1)

James J Peters VA Medical Center; 🇺🇸 Bronx, New York, United States