Effectiveness of Repeated Ketamine Infusions in Treatment Non-Responding Obsessive Compulsive Disorder And its Relation to BDNF: a Double-Blind Randomized COntrolled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Score on the Dimensional Yale Brown Obsessive Compulsive Scale(DY-BOCS)
研究概览
简要总结
The study is a double-blind randomized controlled trial to assess and compare the effectiveness of repeated ketamine infusions and repeated midazolam infusions in treatment non-responding Obsessive Compulsive Disorder and to assess their relation with BDNF. The study will be conducted at a premiere psychiatric institute in India. The primary outcome measures will be 1) scores on the Dimensional Y-BOCS 1hour before ,and 1 hour, 4 hours and 24 hours after each infusion for 2 weeks and after 4 weeks of the last infusion, and 2) plasma levels of BDNF 1 day before 1st infusion, after the 3rd infusion/after 1st week and after the 6th infusion/after 2nd week. The secondary outcome measures will be scores on the Montgomery Asberg Depression Rating Scale, the Hamilton Anxiety Rating Scale, the Clinician Administered Dissociative State Scale and the Systemic Assessment for Treatment Emergent Events Scale, 1 hour before, and 1 hour, 4 hours and 24 hours after each infusion for 2 weeks and after 4 weeks of last infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex, aged between 21-50 years.
- •Inpatients fulfilling ICD 10-DCR diagnostic criteria for OCD but are treatment non-responders.
- •Patients giving written informed consent.
排除标准
- •Any other major co-morbid psychiatric diagnoses (except depression and mild to moderate anxiety) and substance dependence excluding nicotine & caffeine.
- •Presence of an acute/unstable medical or neurological condition.
- •Pregnancy or lactation.
- •Childhood onset OCD (age at onset <10 years) [Geller et al, 1998].
结局指标
主要结局
Score on the Dimensional Yale Brown Obsessive Compulsive Scale(DY-BOCS)
时间窗: DY-BOCS-1 hour before and 1 hour, 4 hours and 24 hours after each infusion for 2 weeks and 4 weeeks after last infusion. | Plasma BDNF-1 day before 1sy infusion, after 3rd infusion or 1st week and after 6th infusion or 2nd week.
Plasma BDNF levels as measured by Sandwich ELISA method
时间窗: DY-BOCS-1 hour before and 1 hour, 4 hours and 24 hours after each infusion for 2 weeks and 4 weeeks after last infusion. | Plasma BDNF-1 day before 1sy infusion, after 3rd infusion or 1st week and after 6th infusion or 2nd week.
次要结局
- Score on the Montgomery Asberg Depression Rating scale (MADRS).(Score on the Hamilton Anxiety Rating Scale(HAM-A))