Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 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 ketamine works in the brain to bring about a reduction in OCD symptoms.
详细描述
The proposed mechanistic trial would be the first to probe the role of ketamine's opioid properties in modulating fronto-striatal circuitry and bringing about reduction of OCD symptoms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Eligibility Criteria for Participants with OCD:
- •Inclusion Criteria:
- •Ages 18-65
- •Meet the criteria for OCD diagnosis
- •Failed at least 1 prior trial of standard first-line OCD treatment
- •Agree to the following lifestyle modifications: comply with requirements for fasting prior to the Experimental 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
- •prior naltrexone or ketamine use/exposure
- •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
- •the presence of metal in the body that is contraindicated for MRI scans
- •Eligibility Criteria for Healthy Volunteers:
- •Inclusion Criteria:
- •Ages 18-65
- •Able to provide informed consent
- •Exclusion Criteria:
- •current or past use of psychotropic medication
- •pregnant or nursing females
- •the presence of metal in the body that is contraindicated for MRI scans
研究组 & 干预措施
Healthy Volunteers
Healthy volunteers will have one fMRI scan visit.
Ketamine + Placebo
OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion. fMRI will be acquired before, during, and after infusion.
An oral inactive placebo will be administered before the infusion.
干预措施: Placebo pill (Other)
Ketamine + Naltrexone
OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion. fMRI will be acquired before, during, and after infusion.
Oral naltrexone 50 mg will be administered before the infusion.
干预措施: Naltrexone Pill (Drug)
Ketamine + Naltrexone
OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion. fMRI will be acquired before, during, and after infusion.
Oral naltrexone 50 mg will be administered before the infusion.
干预措施: Ketamine (Drug)
Ketamine + Placebo
OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion. fMRI will be acquired before, during, and after infusion.
An oral inactive placebo will be administered before the infusion.
干预措施: Ketamine (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 2) to Post Infusion fMRI scan (Visit 4; Day 1), 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