To study Efficacy and safety of Add-on Intravenous Ketamine in Obsessive Compulsive Disorder : A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the effect of intravenous Ketamine in reducing the intensity of Obsessive Compulsive Symptoms within two weeks of administration
研究概览
简要总结
Obsessive Compulsive Disorder is a grossly distressing disease with a long course and significant morbidity and decreased quality of life due to delay in relief of symptoms by first line treatment like selective serotonin reuptake inhibitors or Clomipramine with cognitive behavioural therapy - Exposure Response prevention. This demands for newer interventions as add on . Considering the role of the N-Methyl-D-aspartate receptor (NMDAR) and glutamatergic pathways in the pathophysiology of OCD, ketamine has emerged as a potential therapeutic option with rapid onset of action. Thus, Ketamine as add on therapy will reduce the symptoms and morbidity of Obsessive Compulsive Disorder earlier than medications alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- All
入选标准
- •Patients diagnosed with Obsessive Compulsive Disorder according to ICD-10 and having Y-BOCS score more than 16 Duration more than 6 months with one failed trial of either SSRI or Clomipramine Patients who give their consent.
排除标准
- •Patients who do not give their informed consent.
- •Patients with present diagnosis of cardiovascular disorders, glaucoma, raised intracranial pressure and history of head trauma Pregnant and lactating females Patients with current diagnosis of schizophrenia Patients diagnosed with Mental Retardation Patients having hypersensitivity to ketamine Patients with diagnosis of severe depression.
结局指标
主要结局
To assess the effect of intravenous Ketamine in reducing the intensity of Obsessive Compulsive Symptoms within two weeks of administration
时间窗: To assess the effect of intravenous Ketamine in reducing the intensity of Obsessive Compulsive Symptoms | First assessment at baseline, then on every third day after receiving the infusion (day 0,day 3,day 6,day 9,day 12,day 15) | Then weekly assessment for 4 weeks
次要结局
- To assess phenomenological characteristics which favour response to Ketamine(To assess safety of administration and Adverse Drug Reaction following Ketamine)
研究者
Aashi Srivastava
Kalinga Institute of Medical Sciences