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临床试验/CTRI/2025/03/081539
CTRI/2025/03/081539尚未招募2 期

ASSESSMENTENT OF RAPID ANTIDEPRESSANT EFFECT OT ORAL KETAMINE AS AN ADJUVANT IN SEVERE DEPRESSION -A SINGLE BLIND RANDOMISED CONTROLLED TRIAL

Dr Saumya Mishra1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年3月11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
74
试验地点
1
主要终点
To assess the rapid anti-depressive effect of oral ketamine as an adjuvant antidepressant in

研究概览

简要总结

Ketamine use in depression is becoming increasingly popular in psychiatric practice. The FDA has approved Esketamine nasal spray. Few studies have shown the effectiveness of oral ketamine when used in depression. This study intends to find out the efficacy of oral ketamine

when used as adjuvant treatment in severe depression

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patient aged above 18 yrs of age Patients who have given written informed consent Patient with diagnosis of
  • SINGLE EPISODE DEPRESSIVE DISORDER, severe, without psychotic disorder
  • Recurrent Depressive Disorder, current episode severe without psychotic disorder.

排除标准

  • Bipolar depression Severe depression with psychotic symptoms Pregnant and lactating women Substance abuse (excluding nicotine dependence) Have received ECT in past 2 months Did not give consent for the same.

结局指标

主要结局

To assess the rapid anti-depressive effect of oral ketamine as an adjuvant antidepressant in

时间窗: 1 yr

severe depression

时间窗: 1 yr

次要结局

  • To assess the rapid anti suicidal effect of oral ketamine when given as an adjuvant(1 yr)

研究者

发起方
Dr Saumya Mishra
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR SAUMYA MISHRA

JNMC MEDICAL COLLEGE,KLE

研究点 (1)

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