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临床试验/CTRI/2020/09/027644
CTRI/2020/09/027644已完成3 期

Comparison of acute antidepressant response of IV Ketamine versus oral Ketaminein treatment resistant depression

Dr P N Suresh Kumar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7月9日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
change in clinical ratings of depression in Hamilton Depression Rating Scale

研究概览

简要总结

Severe depressivedisorder is among most debilitating condition. Conventional pharmacotherapyusually takes usually 4–12 weeks to improve symptoms. Ketamine is an N–methyl-Daspartate receptor antagonist having rapid action on depressive symptoms. The objective of the present study is to compare sub-anaesthetic dose of oral versus intravenous ketamine in the acuteantidepressant response in treatment resistant depression in an open labelstudy design.

Sixty drug-free/naïvepatients of either sex, with severe depression having no previous history ofpsychotic disorder, head injury, organic disorder, cardiac problem, orsubstance abuse will be randomly assigned to either oral or intravenous ketamine.All of them will be allowed to continue existing medications without anychanges in dose. Assessments will be made at baseline, day 3, day 5, day 7, day 9, day 11, day 13 and after 1 monthusing Hamilton Depression Rating Scale, Montgomery Asberg Depression RatingScale, BeckDepression Inventory, and Clinical GlobalImpressions (CGI) Scale. The two groups will be compared on various aspects tofind out whether there is any significant difference in the efficacy as well astolerability.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1 Failed 2 trial of different antidepressant class of adequate dose and duration.
  • 2 Current depressive episode is of at least 4 weeks duration.
  • 3 Not received ECT at least prior to enrollment.

排除标准

  • 1 Other psychiatric disorders.
  • 2 Pregnancy and lactation.
  • 3 Concurrent major life-threatening illness like malignancy, cardiac failure, renal failure etc.
  • 4 Alcohol and substance abuse and smokers.
  • 5 Patients with electrocardiogram abnormality or abnormality on fundoscopy.

结局指标

主要结局

change in clinical ratings of depression in Hamilton Depression Rating Scale

时间窗: Day 0,3,5,7,9,11,13

次要结局

  • Changes in Montgomery Asberg Depression rating scale and Clinical Global Impression of severity and Improvement(Day 0,3,5,7,9,11,13 and 1 month)

研究者

发起方
Dr P N Suresh Kumar
申办方类型
Other [Primary sponsor Dr.P.N.Suresh Kumar]

研究点 (1)

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