NCT02019940已完成1 期
An Investigation of the Effects of Riluzole in Patients With Post-Traumatic Stress Disorder (PTSD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Clinician Administered PTSD Scale (CAPS)
研究概览
简要总结
This open label study will evaluate the safety and efficacy of riluzole in patients with PTSD. Patients will receive riluzole 50mg twice per day orally for 12 weeks as outpatient, with a one month follow up at week 16.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between the ages of 18-75 years;
- •Able to provide written informed consent;
- •Current Post Traumatic Stress Disorder, as determined by the Clinician Administered Scale for PTSD, or the presence of sub-threshold PTSD. Individuals with sub-threshold PTSD will be included at the discretion of the PI;
- •Clinician Administered PTSD Scale (CAPS) score of 23 or higher;
- •Be able to understand and speak English.
- •Subjects taking FDA-approved antidepressant medications may enter the study if they have been on a stable dose for at least 4 weeks prior to starting the study drug.
排除标准
- •Breastfeeding women and pregnant women, or women of child bearing potential who are not using a medically accepted means of contraception (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy);
- •Current, ongoing serious suicidal risk as assessed by evaluating investigator or by scoring 5 or more on the item-10 of the MADRS.
- •Unstable medical illness as determined by the investigator;
- •Patients with schizophrenia or schizoaffective disorders (current or past);
- •Substance use disorder during the 3 months prior to screening; except for Cannabis and Alcohol use Disorders.
- •Clinical evidence of untreated hypothyroidism;
- •Patients with any evidence of clinically significant liver abnormalities, or any liver transaminase level > 1.5 x ULN at initial screening, or > 5 x ULN during treatment;
- •Axis II personality disorders that are the primary purpose of treatment, or would interfere with a patient's safety or compliance, as determined by the investigator during open-ended psychiatric interview;
- •Patients currently being treated for a respiratory disorder (including asthma or COPD);
- •For participants over the age of 60, evidence of dementia as determined by the St. Luis University Mental Status Exam (SLUMS; participants with total scores less than or equal to 20 will be excluded and referred to their Primary Care Physician for follow-up/dementia evaluation); Structured psychotherapy focused on treatment of PTSD is exclusionary unless the subject has had at least 8 weeks of treatment prior to starting the study medication;
研究组 & 干预措施
Riluzole
Experimental
Riluzole 50 mg orally twice per day
干预措施: Riluzole (Drug)
结局指标
主要结局
Change in Clinician Administered PTSD Scale (CAPS)
时间窗: Change from baseline to 12 weeks
The CAPS is a standardized clinician-rated instrument to assess the presence and severity of PTSD symptoms. The scores range from 0 (minimum) to 80 (mazimum). Higher scores reflect worse symptoms.
次要结局
- Post-Traumatic Stress Disorder Checklist (PCL)(12 weeks)
- Clinical Global Impressions Scale(12 weeks)
- Montgomery-Asberg Depression Rating Scale (MADRS)(12 weeks)
研究者
研究点 (1)
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