NCT00691067已完成4 期
A Randomized, Double-blind Placebo-controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- change in the health components score of the veterans RAND 36-item health survey (VR-36)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran of the 1991 Gulf War
- •Veteran meets criteria for multisymptom illness
排除标准
- •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
研究组 & 干预措施
Mifepristone
Experimental
600mg of Mifepristone
干预措施: mifepristone (Drug)
Placebos
Placebo Comparator
Placebo
干预措施: Placebos (Drug)
结局指标
主要结局
change in the health components score of the veterans RAND 36-item health survey (VR-36)
时间窗: baseline, every two weeks, endpoint
次要结局
- cognitive functioning and measures of depression, fatigue and PTSD(baseline and endpoint)
研究者
Julia Golier
Clinical Director, Mental Health Patient Care Center
Bronx Veterans Medical Research Foundation, Inc
研究点 (1)
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