跳至主要内容
临床试验/CTRI/2022/04/042071
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

Ahana Hospitals LLP1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月25日最近更新:

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

申办方类型
Private hospital/clinic

研究点 (1)

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