- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00691067
A Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
January 30, 2017 updated by: Julia Golier, Bronx Veterans Medical Research Foundation, Inc
A Randomized, Double-blind Placebo-controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Bronx, New York, United States, 10468
- James J Peters VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mifepristone
600mg of Mifepristone
|
200 mg po per day x 6 weeks
|
Placebo Comparator: Placebos
Placebo
|
placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in the health components score of the veterans RAND 36-item health survey (VR-36)
Time Frame: baseline, every two weeks, endpoint
|
baseline, every two weeks, endpoint
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cognitive functioning and measures of depression, fatigue and PTSD
Time Frame: baseline and endpoint
|
baseline and endpoint
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Julia A Golier, M.D., James J Peters VA Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
June 3, 2008
First Submitted That Met QC Criteria
June 4, 2008
First Posted (Estimate)
June 5, 2008
Study Record Updates
Last Update Posted (Estimate)
January 31, 2017
Last Update Submitted That Met QC Criteria
January 30, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Abortifacient Agents
- Luteolytic Agents
- Abortifacient Agents, Steroidal
- Contraceptives, Postcoital, Synthetic
- Contraceptives, Postcoital
- Menstruation-Inducing Agents
- Mifepristone
Other Study ID Numbers
- GW060048
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Multisymptom Illness in Gulf War Veterans
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Bronx Veterans Medical Research Foundation, IncBoston University; VA Boston Healthcare SystemUnknownChronic Multisymptom Illness in Gulf War VeteransUnited States
-
VA Office of Research and DevelopmentGeorgetown University; MedStar HospitalsCompleted
-
National Institute of Neurological Disorders and...RecruitingGulf War IllnessUnited States
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East Carolina UniversityCompletedGulf War IllnessUnited States
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K-PAX Pharmaceuticals, Inc.VA Palo Alto Health Care SystemUnknownGulf War IllnessUnited States
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VA Office of Research and DevelopmentTexas A&M UniversityTerminatedGulf War IllnessUnited States
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Icahn School of Medicine at Mount SinaiUnited States Department of Defense; Department of Veterans Affairs, New JerseyCompletedGulf War IllnessUnited States
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-
Boston University Charles River CampusUnknownGulf War IllnessUnited States
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