NCT01956279已完成2 期
Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Physical Component of the SF-36
研究概览
简要总结
This study will investigate the use of adjunctive pregnenolone for the following:
- fatigue that has limited usual activity,
- musculoskeletal pain involving 2 or more regions of the body and,
- cognitive symptoms (memory, concentration, or attentional difficulties by self-report) in Veterans deployed to the Gulf War theatre of operations between 1990 and 1991.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans deployed to the Gulf War theatre of operations between 1990 and
- •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.
排除标准
- •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 suggested no effects on menstrual cycle, alterations in downstream metabolites or pregnenolone (such as estradiol) could theoretically impact the efficacy or oral contraceptives and/or estrogen replacement]. Similarly, it is theoretically possible that pregnenolone could be metabolized to other steroids such a DHEA, potentially resulting in hair, skin, or other steroid-related changes. Since the investigators' have determined in their prior study that pregnenolone administration does not result in downstream elevations in DHEA, DHEAS, estradiol, or testosterone, these possibilities may be unlikely.
- •Women who are breast-feeding.
- •Use of narcotic interventions.
- •Known allergy to study medication.
- •History of moderate or severe TBI (with loss of consciousness greater than 30 minutes)
- •A clearly defined disease entity that accounts for the Veteran's symptoms.
- •Current DSM-IV/DSM-IVTR/DSM-V diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder, or dementia.
- •Subjects with a DSM-IV/DSM-IVTR/DSM-V diagnosis of alcohol or substance dependence (other than nicotine or caffeine) within the last month.
- •Subjects with a current suicidal or homicidal ideation necessitating clinical intervention or representing an imminent concern.
- •If in the judgment of the PI it is not in the subject's best interest to participate.
- •Final eligibility decisions will be determined by the PI.
研究组 & 干预措施
Pregnenolone (Arm 1)
Experimental
Pregnenolone
干预措施: Pregnenolone (Drug)
Placebo (Arm 2)
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Physical Component of the SF-36
时间窗: Baseline to week 4, and Baseline to week 8
These data report changes in the mean scores in physical health symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SF-36 is a health survey with an 8-scale profile embedded in 36 questions that measures physical and mental components of health. Each item is scored on a 0 to 100 range, with the lowest and highest possible scores set at 0 and 100, respectively. All of these items are scored such that a high score defines a more favorable health state, and the Physical Component Score is an average of 4 of the 8 domains of the SF-36. Thus, positive changes in scores represent an improvement relative to baseline.
次要结局
- Brief Pain Inventory (BPI)(Baseline to week 4, and Baseline to week 8)
- Tower of London Test of the Brief Assessment of Cognition in Affective Disorders (BAC-A)(Baseline to week 4, and Baseline to week 8)
- Multidimensional Fatigue Inventory (MFI)(Baseline to week 4, and Baseline to week 8)
- Global Severity Index of the Symptom Checklist-90-Revised (SCL-90R)(Baseline to week 4, and Baseline to week 8)
研究者
研究点 (1)
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