Understanding the Glutamate System in Adults With Obsessive-Compulsive Disorder With N-methyl-D Aspartate Antagonist Ketamine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 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
In this study investigators are studying the effects of a drug called ketamine on the symptoms of Obsessive-compulsive disorder (OCD).
详细描述
Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study the investigators are recruiting patients to receive the drug ketamine, which is thought to modulate the neurotransmitter glutamate through the N-methyl-D-aspartate (NMDA), in a 2-week placebo controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Age 18-55
- •Physically healthy and not currently pregnant
- •Primary Diagnosis of OCD
- •Sufficient severity of symptoms
- •Able to provide consent
排除标准
- •Psychiatric conditions that make participation unsafe
- •Currently on psychotropic medication
- •Medical conditions that make participation unsafe
- •Allergy to ketamine
- •Any metal in the body
研究组 & 干预措施
Group A
0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
干预措施: Ketamine infusion (Drug)
Group A
0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
干预措施: Saline (Other)
Group B
IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
干预措施: Ketamine infusion (Drug)
Group B
IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
干预措施: Saline (Other)
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: 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
