NCT04630444已完成早期 1 期
An Investigational Study of Riluzole Effects on Hippocampus Biomarkers
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Assessing the clinical efficacy of riluzole in PTSD
研究概览
简要总结
To examine the clinical efficacy of the anti-glutamatergic medication riluzole in posttraumatic stress disorder (PTSD), and its effect on hippocampus biomarkers that our laboratory previously has identified using MRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 18-
- •Right handed
- •Able to provide written informed consent.
- •Meets DSM-5 criteria for PTSD (current month and past 3 months).
- •If already receiving psychiatric intervention(s), must be on a stable regimen.
- •Has normal physical examination, laboratory test results, and electrocardiogram results at pre-treatment visit.
排除标准
- •Unwillingness or inability to provide written informed consent.
- •Unable to swallow pills.
- •Unable to tolerate blood draws.
- •Currently enrolled in another intervention study.
- •Imminent risk for self-harm (assessed by a licensed clinician)
- •Active psychotic symptoms.
- •Current panic disorder.
- •Lifetime history of schizophrenia spectrum disorder, bipolar disorder, obsessive compulsive disorder, anorexia nervosa, seizure disorder, or neurologic disorder.
- •Urine toxicology positive for drug(s) of abuse.
- •Evidence of any clinically significant medical disease.
- •Women who test positive for ß-HCG, self-report as pregnant, or are nursing.
- •Substance or alcohol abuse within 3 months of Visit
- •Substance or alcohol dependence within 6 months of Visit
- •Excessive caffeine use, defined as regular consumption of >700mg caffeine per day.
- •Treatment with an antipsychotic, valproate, other anticonvulsant, reversible MAOI within 4 weeks of Visit
- •Other excluded medications will be those with (1) known glutamatergic effects, (2) previous MRS evidence of effects on brain glutamate, (3) potential effects on riluzole levels or (4) risk of neutropenia - used within 4 weeks of the first study visit.
- •Previous exposure to riluzole or ketamine.
- •Treatment with any investigational medicine within 30 days of Visit
- •Treatment with electroconvulsive therapy (ECT) within 3 months of Visit
- •Uncorrected thyroid disease.
- •Any screening laboratory assay that is deemed to be a clinically significant abnormality by the investigator, with the exception of liver function tests (AST, ALT, alkaline phosphatase), which must be within 1.5 times the upper limit of normal.
- •Any contraindications to having an MRI scan.
研究组 & 干预措施
Intervention Group
Experimental
30 PTSD patients receiving riluzole 100 mg daily (50 mg bid).
干预措施: Riluzole (Drug)
结局指标
主要结局
Assessing the clinical efficacy of riluzole in PTSD
时间窗: weeks 1-8
Testing the hypothesis that riluzole monotherapy will yield within-subject reductions in PTSD intrusion symptoms (CAPS intrusion subscale)
次要结局
未报告次要终点
研究者
Isabelle Rosso
Associate Professor
Mclean Hospital
研究点 (1)
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