CTRI/2021/10/037627尚未招募3 期
Efficacy and safety of ADD-ON intravenous Ketamine in DSM-V diagnosed severe depressive disorder;a double blind controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- KIMS
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Outcome of treatment will be measured in terms of reduction of the HAM-D score by more than 50%
研究概览
简要总结
This is Randomised controlled trial studing safety and efficacy of add on Ketamine in patient of severe 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
- All
入选标准
- •Patients diagnosed with severe depression according to the DSM-5 guidelines and ham-d score suggesting Depression.
- •Patients who give their consent.
排除标准
- •1.Patients with present diagnosis or antecedents of clinically relevant cardiovascular disorder such as stroke, heart attack,etc 2.Patients with present or past diagnosis of glaucoma, intracranial hypertension 3.Patients with current diagnosis of schizophrenia and related disorder 4.Significant ECG abnormalities 5.History of neurological disease or prior head trauma with evidence of cognitive impairment 6.Known hypersensitivity to ketamine 7.Patients who donot give their informed consent.
结局指标
主要结局
Outcome of treatment will be measured in terms of reduction of the HAM-D score by more than 50%
时间窗: by at the end of two weeks
次要结局
- Reduction in the score of suicidal risk(Improvement in the global functioning)
研究者
研究点 (1)
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