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

A Randomized, Double-blind Placebo-controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00691067

Enrollment

Registered

2008-06-05

Start date

2008-05-31

Completion date

2012-08-31

Last updated

2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Multisymptom Illness in Gulf War Veterans

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.

Interventions

DRUGmifepristone

200 mg po per day x 6 weeks

DRUGPlacebos

placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
cognitive functioning and measures of depression, fatigue and PTSD	baseline and endpoint

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026