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临床试验/CTRI/2024/03/064734
CTRI/2024/03/064734招募中3 期

A proof-of-concept study to compare the effectiveness and tolerability of convulsive versus sub-convulsive stimuli of modified electroconvulsive therapy - NI

All India Institute of Medical Sciences New Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Age 18-60 years
  • 2.Willing to give informed consent
  • 3.Ability to read Hindi or English language
  • 4.Fulfilling criteria of major depressive disorder as per Diagnostic and Statistical Manual 5th version (DSM 5) in group 1 & 2
  • 5.Treatment resistance will be defined as the failure to respond to 2 adequate trials of different classes of antidepressant medications (Sackeim, 2001)
  • 6.Patients referred for ECT (for all study patients, a clinical decision to pursue neuromodulation would have already been made. Clinical treatment will be performed independently of this study).
  • 7.No changes in psychiatric medications for at least one month prior to study and willingness to not change during study

排除标准

  • 1.Patients with chronic neurological or other physical illness (like coronary artery disease or cardiac arrhythmia)
  • 2.Suffering from any other psychiatric disorder other than major depressive disorder in their respective groups
  • 3.Persistent mood disorders (dysthymia) and other and unspecified depressions based on DSM 5
  • 4.History of significant head trauma
  • 5.Patients with ongoing alcohol or other substance abuse or dependence (except nicotine and caffeine)
  • 6.Any history of seizure
  • 7.Previous history of receiving any surgical procedures or electrical or magnetic stimulation on brain
  • 8.Known or suspected pregnancy or lactating females
  • 9.History of serious, potentially life-threatening reaction to anesthesia or succinylcholine

研究者

发起方
All India Institute of Medical Sciences New Delhi

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