Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With Obsessive Compulsive Disorder (OCD)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 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
Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that are FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3 months), and even then they usually only partially reduce OCD symptoms. The present study, will test if intranasal ketamine is feasible to use and can reduce OCD symptoms significantly more than a comparison medication called midazolam. Therefore, you may or may not receive ketamine as part of this study. Results from this study will allow doctors and researchers to better understand if you and others with OCD may respond to this class of medications.
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, Investigator, Outcomes Assessor)
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
- •For all patients on medications, medications dose must be stable for at least 6 weeks prior to enrollment. Must discuss with Dr. current medications and doses.
- •Able to provide consent
排除标准
- •First degree relative with schizophrenia
- •Psychiatric conditions that would make participation unsafe determined by study doctor
- •Female patients who are either pregnant or nursing
- •Planning to start 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.
- •Nasal obstruction or history of nasal surgery
- •Currently on psychotropic medication or other medication likely to interact with the glutamate system
- •Medical conditions that make participation unsafe
- •Allergy or intolerance to ketamine or midazolam
研究组 & 干预措施
Midazolam
A single dose of intranasal midazolam up to 4 mg
干预措施: Intranasal Midazolam (Drug)
Ketamine
A single dose of intranasal ketamine up to 50 mg
干预措施: Intranasal Ketamine (Drug)
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: Baseline and 1 Week
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