跳至主要内容
临床试验/NCT01100255
NCT01100255已完成2 期

Understanding the Glutamate System in Adults With Obsessive-Compulsive Disorder With N-methyl-D Aspartate Antagonist Ketamine

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年4月最近更新:
适应症
干预措施

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

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

Active Comparator

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

Active Comparator

0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes

干预措施: Saline (Other)

Group B

Active Comparator

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

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验