| June 3, 2008 |
| June 4, 2008 |
| May 2008 |
| May 2011 (final data collection date for 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 ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00691067 on ClinicalTrials.gov Archive Site |
| cognitive functioning and measures of depression, fatigue and PTSD [ Time Frame: baseline and endpoint ] [ Designated as safety issue: No ] |
| Same as current |
| |
| 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 |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study |
| Chronic Multisymptom Illness in Gulf War Veterans |
- Drug: mifepristone
- Drug: placebo
|
| |
| |
| |
| Recruiting |
| 40 |
| May 2011 |
| May 2011 (final data collection date for primary outcome measure) |
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 has a fasting blood glucose ≥ 110 mcg/dl
- 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
|
| Both |
| 35 Years and older |
| No |
|
|
| United States |
| |
| NCT00691067 |
| Julia Golier, M.D., James J Peters VA Medical Center |
| GW060048 |
| Bronx Veterans Medical Research Foundation, Inc |
| U.S. Army Medical Research and Materiel Command |
| Principal Investigator: |
Julia A Golier, M.D. |
James J Peters VA Medical Center |
|
|
| Bronx Veterans Medical Research Foundation, Inc |
| June 2008 |
