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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Understanding GWI: Integrative Modeling

NCT04255498

Gulf War Illness Persian Gulf Syndrome Occupational Diseases

UNKNOWN PHASE1

A Randomized, Double-Blind, Parallel, Non-Inferiority, Multicenter Trial Evaluate the Efficacy and Safety of UNCNT Compared to MELSMON in Female With Menopausal Syndrome

NCT01931748

Menopausal Syndrome

COMPLETED PHASE3

A Randomized, Double Blind, Placebo Controlled, Clinical Study to Examine the Benefits of an Oral Product in Panelists With Menopausal Symptoms Including Vasomotor Symptoms (VMS).

NCT07033013

Healthy

RECRUITING NA

One Week Clinical Study in Subjects With Menopausal Symptoms

NCT06794021

Healthy Menopause

COMPLETED NA

MyHealtheVet to Enable Shared Decision Making Regarding Menopausal in Postmenopausal Women Veterans (MEANS)

NCT03109145

Menopause

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Multisymptom Illness in Gulf War Veterans

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mifepristone

600mg of Mifepristone

Group Type EXPERIMENTAL

mifepristone

Intervention Type DRUG

200 mg po per day x 6 weeks

Placebos

Placebo

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mifepristone

200 mg po per day x 6 weeks

Intervention Type DRUG

Placebos

placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No