Novel Therapeutics in PTSD: A Randomized Clinical Trial of Mifepristone
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline on the total severity of the CAPS-2 and dichotomously defined clinical responder status.
研究概览
简要总结
The investigators propose to conduct a randomized double-blind, parallel-group, placebo-controlled trial of mifepristone in veterans with military-related posttraumatic stress disorder (PTSD). This study will examine the clinical, neuropsychological, and neuroendocrine effects of short-term treatment of mifepristone (600 mg/day for one week) to determine if this treatment is efficacious in improving PTSD symptoms, cognitive functioning, or other related clinical measures. Additionally, the investigators will observe whether baseline neuroendocrine activity, or other clinical or neuropsychological factors predict the response to mifepristone, and whether mifepristone-induced changes in neuroendocrine activity are associated with treatment outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject is a male U.S. veteran
- •Subject was exposed to combat or another criterion A traumatic event during military service
- •Subject meets diagnostic criteria for chronic PTSD
排除标准
- •Veteran has a history of adrenal insufficiency or a plasma cortisol level less than 5 mcg/dl at screening
- •Veteran has a moderate-severe traumatic brain injury, a history of a stroke, or another neurological illness or injury likely to impact cognitive functioning
- •Veteran has diabetes mellitus, an endocrinopathy, or another major medical illness.
- •Veteran is taking oral corticosteroids
- •Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
- •Veteran is currently suicidal or otherwise is in need of urgent clinical care
- •Veteran is currently receiving specialized trauma-focused psychotherapy (i.e., prolonged exposure, cognitive processing therapy or eye movement and desensitization reprocessing).
- •Veteran is not willing to use effective means of birth control during the study or for 90 days after taking study medication
- •Veteran has history of allergic reaction to mifepristone
研究组 & 干预措施
1
mifepristone
干预措施: mifepristone (Drug)
2
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline on the total severity of the CAPS-2 and dichotomously defined clinical responder status.
时间窗: baseline, endpoint, 4 week follow-up
次要结局
- Change in cognitive functioning as measured by the MATRICS neuropsychological test battery and self-reported measures of depression and PTSD.(baseline, endpoint, 4 week follow-up)
研究者
Julia A. Golier, M.D.
Clinical Director, Mental Health Patient Care Center
James J. Peters Veterans Affairs Medical Center