A RANDOMIZED PLACEBO-CONTROLLED CROSSOVER TRIAL OF LOW-DOSE XENON FOR THE TREATMENT OF OBSESSIVE-COMPULSIVE DISORDER
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Decrease in OCD Symptoms
研究概览
简要总结
The primary purpose of this study is to investigate whether administration of xenon reduces symptoms of Obsessive-Compulsive Disorder (OCD). Xenon is a naturally occurring gas that has been used in clinical settings both as a general anesthetic agent and as a contrast agent for computed tomography (CT) scans. Investigators believe that xenon may be effective in reducing symptoms of OCD due to its ability to reduce the activity of a specific brain chemical called glutamate, which has been shown to be abnormal in the brains of people with OCD.
It is important to understand that this study uses a placebo, or inactive, treatment. In this study, the placebo treatment is inhalation of room air (instead of xenon). All participants will receive both xenon and placebo treatments at some point over the course of the study. However, neither the participants nor the study investigators will know which treatment you are receiving.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age ≥ 18 and ≤ 55
- •Meets DSM-IV criteria for OCD as primary presenting disorder
- •Score of ≥ 18 on the Y-BOCS at screening (Visit 1).
排除标准
- •Unwillingness or inability to provide written informed consent.
- •Lifetime history of schizophrenia or autism spectrum disorder
- •Diagnostic and Statistical Manual IV (DSM-IV) diagnosis of alcohol or substance dependence, with the exception of nicotine dependence, within three months prior to screening
- •Clinically significant medical disease including, but not limited to, pulmonary, cardiac (including uncontrolled hypertension), hepatic, renal, or endocrine disorders, which would increase the risk to the participant or interfere with interpretation of results as judged by the principal investigator.
- •Clinically significant neurologic disease including, but not limited to, seizure disorder, neurodegenerative diseases, and history of traumatic brain injury that would increase the risk to the participant or interfere with interpretation of results as judged by the principal investigator.
- •Female participants with a positive urine pregnancy test at screening
- •Pregnancy. Females of childbearing potential must be using an effective contraceptive method (e.g., abstinence, prescription oral contraceptives, contraceptive injections, double-barrier method, male partner sterilization).
- •Any screening laboratory abnormality deemed clinically significant by the investigator
研究组 & 干预措施
Xenon/Placebo
Participants in this group will receive three treatments of 25% xenon followed by 3 treatments of placebo (room air).
干预措施: Xenon (Drug)
Xenon/Placebo
Participants in this group will receive three treatments of 25% xenon followed by 3 treatments of placebo (room air).
干预措施: Placebo (Drug)
Placebo/Xenon
Participants in this group will receive three treatments of placebo (room air) followed by three treatments of 25% xenon.
干预措施: Xenon (Drug)
Placebo/Xenon
Participants in this group will receive three treatments of placebo (room air) followed by three treatments of 25% xenon.
干预措施: Placebo (Drug)
结局指标
主要结局
Decrease in OCD Symptoms
时间窗: Baseline to Week 5
Xenon is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of three treatments when compared to placebo (room air).
次要结局
- Decrease in Depressive Symptoms(Baseline to Week 5)