A Double-blind, Placebo-controlled Study to Determine the Safety and Feasibility of Two Doses of Intravenous (2R, 6R)-Hydroxynorketamine (RR-HNK) in Adults With Obsessive-Compulsive Disorder
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
研究概览
简要总结
The purpose of this study is to understand how RR-HNK works in the brain to bring about a reduction in OCD symptoms.
详细描述
This protocol examines the safety and efficacy of 2 dosage levels of intravenous RR-HNK administration in individuals with OCD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Ages 18-65
- •Meet the criteria for OCD diagnosis
- •Failed at least 1 prior trial of standard first-line OCD treatment (e.g. SRI/CBT) or or had refused these treatments for individual reasons
- •Agree to the following lifestyle modifications: comply with requirements for fasting prior to --the infusion session, not enroll in any other interventional clinical trials during the duration of the study, and commit to medication study procedures.
- •Able to provide informed consent
排除标准
- •Allergy or hypersensitivity to ketamine
- •Any current or past medical/psychiatric condition that makes participation unsafe in the opinion of the investigator or study physician
- •Pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control
- •Lifetime history of deep brain stimulation
研究组 & 干预措施
0.25 mg/kg RR-HNK
OCD patients in this arm will receive 0.25mg/kg of RR-HNK - one single infusion. EEG and computerized behavioral tests will be acquired before and after infusion.
干预措施: RR-HNK/Hydroxynorketamine (Drug)
0.5 mg/kg RR-HNK
OCD patients in this arm will receive 0.5mg/kg of RR-HNK - one single infusion. EEG and computerized behavioral tests will be acquired before and after infusion.
干预措施: RR-HNK/Hydroxynorketamine (Drug)
Placebo (Sterile Saline)
OCD patients in this arm will receive sterile saline - one single infusion. EEG and computerized behavioral tests will be acquired before and after infusion.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
时间窗: Baseline (Visit 3) to Week 1 (Visit 8), up to 1 week
Change in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS.
次要结局
未报告次要终点
研究者
Carolyn Rodriguez
Professor
Stanford University