Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI) (NCT01956279) | Clinical Trial Compass
CompletedPhase 2
Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)
United States170 participantsStarted 2013-10-01
Plain-language summary
This study will investigate the use of adjunctive pregnenolone for the following:
1. fatigue that has limited usual activity,
2. musculoskeletal pain involving 2 or more regions of the body and,
3. cognitive symptoms (memory, concentration, or attentional difficulties by self-report) in Veterans deployed to the Gulf War theatre of operations between 1990 and 1991.
Who can participate
Age range40 Years – 65 Years
SexALL
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Inclusion Criteria:
* Veterans deployed to the Gulf War theatre of operations between 1990 and 1991.
* Veterans who report at least 2 of the following 3 symptoms that began in 1990 or thereafter, that lasted for more than 6 months, and that are present at the time of screening: 1) fatigue that limited usual activity, 2) musculoskeletal pain involving 2 or more regions of the body, 3) cognitive symptoms (memory, concentration, or attentional difficulties by self-report)
* Stable on medication regimen (no change in last 4 weeks) and no anticipated change in medication during study.
* Able to provide informed consent for study participation.
Exclusion Criteria:
* Subjects with a history of clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorders (e.g. unstable angina, seizures, cerebrovascular accident, decompensated congestive heart failure, central nervous system (CNS) infection, cancer \[other than non-melanoma skin cancer\], or history of HIV seropositivity), which would pose a risk to the patient if s/he were to participate in the study or that might confound the results of the study.
* Concurrent enrollment in another clinical trial.
* Pregnant women or women of child-bearing potential who are not surgically-sterile or not using appropriate methods of birth control.
* Use of oral contraceptives or other hormonal supplementation such as estrogen \[although early studies suggest…
What they're measuring
1
Physical Component of the SF-36
Timeframe: Baseline to week 4, and Baseline to week 8