CTRI/2022/04/042071尚未招募不适用
Clinical utility of adjuvant ketamine in first episode depression- a double blind, placebo controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hamilton Depression rating scale (HAM-D) to assess severity of depression
研究概览
简要总结
Ketamine has been widely explored for its therapeutic effects on various psychiatric illnesses. Many studies have brought to light its role in treatment-resistant depression. Though ketamine is found to have rapid antidepressant activity, no study has explored its use as an add-on in the first episode depression. A quick relief from one of the most disabling disorders enables an individual to get back to his/her daily activities as early as possible and also significantly reduces the distress associated with it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •Participants willing to sign a written informed consent document; Participants must fulfill ICD criteria for Depressive episode , with the severity being moderate to severe 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 Women who are pregnancy or breastfeeding Those who are allergic to ketamine.
结局指标
主要结局
Hamilton Depression rating scale (HAM-D) to assess severity of depression
时间窗: baseline, day 2, day 14
次要结局
- Beck Scale for Suicidal Ideation (BSSI) to assess the level of suicidal ideation(baseline, day 2 and day 14)
研究者
研究点 (1)
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