Chronic Multisymptom Illness in Gulf War VeteransPhase 4NCT00691067
A Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
A Phase 4 study testing mifepristone in people with Chronic Multisymptom Illness in Gulf War Veterans, run by Bronx Veterans Medical Research Foundation, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Multisymptom Illness in Gulf War Veterans
- What is being tested?
- mifepristone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Aug 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran of the 1991 Gulf War
- Veteran meets criteria for multisymptom illness
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
James J Peters VA Medical Center
The Bronx, New York, 10468
About this study
Official title: 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.
- Being tested
- mifepristone, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mifepristoneDrug
200 mg po per day x 6 weeks
PlacebosDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone | Experimental | 600mg of Mifepristone Receives: Drug: mifepristone |
| Placebos | Placebo comparator | Placebo Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the health components score of the veterans RAND 36-item health survey (VR-36)
Measured: baseline, every two weeks, endpoint
Secondary outcomes (1)
cognitive functioning and measures of depression, fatigue and PTSD
Measured: baseline and endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Multisymptom Illness in Gulf War VeteransStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bronx Veterans Medical Research Foundation, Inc
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, Julia Golier, Bronx Veterans Medical Research Foundation, Inc
- Investigators
- Julia A Golier, M.D., Principal investigator, James J Peters VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691067
- Sponsor's protocol ID
- GW060048
- Status last verified
- Jan 2017
- First submitted
- 3 Jun 2008
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Golier JA, Caramanica K, Michaelides AC, Makotkine I, Schmeidler J, Harvey PD, Yehuda R. A randomized, double-blind, placebo-controlled, crossover trial of mifepristone in Gulf War veterans with chronic multisymptom illness. Psychoneuroendocrinology. 2016 Feb;64:22-30. doi: 10.1016/j.psyneuen.2015.11.001. Epub 2015 Nov 10.
PubMed 26600007
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Placebo-controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
- ClinicalTrials.gov ID
- NCT00691067
- Acronym / sponsor ID
- GW060048
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Bronx Veterans Medical Research Foundation, IncUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- May 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone | Experimental | Drug: mifepristone600mg of Mifepristone |
| Placebos | Placebo comparator | Drug: PlacebosPlacebo |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veteran of the 1991 Gulf War
- Veteran meets criteria for multisymptom illness
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mifepristone200 mg po per day x 6 weeks | Drug | Mifepristone |
| Placebosplacebo | Drug | Placebos |
Primary outcome
change in the health components score of the veterans RAND 36-item health survey (VR-36)
Time frame: baseline, every two weeks, endpoint
1 secondary outcome
cognitive functioning and measures of depression, fatigue and PTSD
Time frame: baseline and endpoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Derived from this study: PubMed 26600007Golier JA, Caramanica K, Michaelides AC, Makotkine I, Schmeidler J, Harvey PD, Yehuda R. A randomized, double-blind, placebo-controlled, crossover trial of mifepristone in Gulf War veterans with chronic multisymptom illness. Psychoneuroendocrinology. 2016 Feb;64:22-30. doi: 10.1016/j.psyneuen.2015.11.001. Epub 2015 Nov 10.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia A Golier, M.D. principal investigator
James J Peters VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mifepristone in people with Chronic Multisymptom Illness in Gulf War Veterans, run by Bronx Veterans Medical Research Foundation, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the health components score of the veterans RAND 36-item health survey (VR-36) (time frame: baseline, every two weeks, endpoint). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00691067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.