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临床试验/CTRI/2024/09/073722
CTRI/2024/09/073722尚未招募2 期

Comparison of the rapid anti-depressant effects of Ketamine vs Thiopentone assisted Modified Electro Convulsive Therapy in patients with Severe Depression-A hospital based Randomised Control Trial.

Dr Jaya Rama Rao Ponnamanda1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年9月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
To compare the rapid anti-depressant effects of Ketamine assisted vs thiopentone assisted modified ECT

研究概览

简要总结

This study aims to compare the rapid anti depressant effects and Cognitive effects of Ketamine Vs Thiopentone assisted modified Electro Convulsive therapy(ECT) in patients with Severe Depression. Thiopentone is the routinely used drug for induction in Modified ECT. Ketamine is a newer drug which is widely known for it rapid antidepressant properties. This study will use Ketamine as an induction agent in one arm and compare the antidepressant effects and effect in cognitive decline compared to Thiopentone which will be used in the other arm.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • Single Episode Depressive disorder, severe, without psychotic symptoms.
  • Recurrent depressive disorder, current episode severe, without psychotic symptoms.
  • Bipolar Type I disorder, current episode depressive,severe without psychotic symptoms.
  • Bipolar Type II disorder, current episode depressive, severe without psychotic symptoms.

排除标准

  • Severe depression with presence of psychotic symptoms -Primary psychotic disorder.
  • Mixed episode.
  • Pregnant and Lactating females.
  • Severe medical conditions such as Renal failure, Hypertension, IHD.

结局指标

主要结局

To compare the rapid anti-depressant effects of Ketamine assisted vs thiopentone assisted modified ECT

时间窗: 1 year

次要结局

  • To compare the cognitive effects in patients who have reveived Modified ECT under Ketamine and Modified ECT under Thiopentone(1 year)

研究者

发起方
Dr Jaya Rama Rao Ponnamanda
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Jaya Rama Rao Ponnamanda

Jawaharlal Nehru Medical college

研究点 (1)

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