A randomized, double-blind placebo controlled study of clinical utility of multiple ketamine infusion in treatment resistant Obsessive Compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Outcome measures were (i) a reduction in illness severity on the YBOCS scale compared to baseline scores, and (ii) response [as defined
研究概览
简要总结
Serotonin reuptake inhibitors (SRIs) and cognitive behavioural therapy- exposure and response prevention (CBT- ERP) are the first line treatment option for obsessive compulsive disorder (OCD). However, one third of the OCD patient do not respond to this treatment. This implies a need for novel pharmacological treatment option. Recently there has been considerable interest in the anti-obsessional effect of glutamate-modulating drugs such as memantine, N-acetyl cysteine and ketamine. However to the best of our knowledge, data on the use of ketamine in OCD is limited. Hence a study on the use of multiple ketamine infusions for treatment resistant OCD was conceived, based on the data available on its efficacy in patients with depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Participants must be willing to give a written informed consent document; Participants must fulfill DSM-5 criteria for Obsessive Compulsive Disorder, and should have been resistant to at least 2 SSRI trails of adequate dose and duration and psychotherapy.
- •Participants must be medically and neurologically healthy.
排除标准
- •Those who have neurological disorders, severe medical illness, mental retardation and co-morbid psychiatric diagnoses such as psychosis, substance dependence Women who are pregnancy or breastfeeding Those who are allergic to ketamine.
结局指标
主要结局
Outcome measures were (i) a reduction in illness severity on the YBOCS scale compared to baseline scores, and (ii) response [as defined
时间窗: at baseline, 2 weeks, 4 weeks
by ≥35 % reduction (response) and 25–35 % reduction (partial response)] on the YBOCS total score.
时间窗: at baseline, 2 weeks, 4 weeks
次要结局
- Outcome measures were a reduction in depression severity on the HAM-D scale compared to baseline scores.(at baseline, 2 weeks, 4 weeks)