Extending Ketamine's Effects in Obsessive-Compulsive Disorder (OCD) With Exposure and Response Prevention (EX/RP)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale
研究概览
简要总结
This study investigates if a single dose of IV Ketamine can rapidly improve Obsessive-Compulsive Disorder (OCD) symptoms and whether these effect can be maintained with a condensed course of a type of Cognitive Behavioral Therapy called Exposure and Response Prevention (EX/RP). You will be compensated for your time and travel. Participants must be between the ages of 18-55.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55
- •Physically healthy and not currently pregnant
- •Primary Diagnosis of OCD
- •Sufficient severity of symptoms
- •Currently off all psychotropic medication OR
- •Currently on adequate dose of medication for treatment of OCD, but have not achieved at least partial remission
- •Able to provide consent
排除标准
- •Psychiatric conditions that make participation unsafe (schizophrenia [either self or first degree relative e.g. siblings, parents], history of violence, severe depression, eating disorder, substance dependence [including nicotine])
- •Female patients who are either pregnant or nursing
- •Planning to commence EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment.
- •period of the study
- •Allergy to ketamine
- •Participants for whom being off of medication is not clinically recommended
- •Medical conditions that make participation unsafe (e.g. high blood pressure, head injury)
- •Currently on medications that make participation unsafe
研究组 & 干预措施
Ketamine, Exposure & Response Prevention
0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)
干预措施: Ketamine (Drug)
Ketamine, Exposure & Response Prevention
0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)
干预措施: Exposure and Response Prevention (Behavioral)
结局指标
主要结局
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale
时间窗: 2 weeks
Patients given 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 was defined as at least a 35% reduction on the YBOCS.
次要结局
未报告次要终点