跳至主要内容
临床试验/ACTRN12621001186842
ACTRN12621001186842暂停未知

Acceptability and Tolerability of Transcranial Magnetic Stimulation for Depression in Adolescents and Young Adults.

Orygen0 个研究点目标入组 40 人开始时间: 2021年9月3日最近更新:
适应症

试验速览

阶段
未知
状态
暂停
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
15 Years 至 25 Years(—)
性别
All

入选标准

  • A participant will be considered eligible for inclusion in this study only if ALL of the following criteria apply:
  • Aged 15 – 25years old
  • Capacity to consent
  • Current major depressive episode as determined by psychiatrist/ psychiatry trainee (persons with BPAD in a depressive phase can be included)
  • A QIDS-C of > 10 (moderate to severe depression)
  • Treatment resistance defined as a failure to respond to first-line treatment with structured psychotherapy or antidepressant medication
  • If taking psychotropic medication regime, on a stable dose in the four weeks prior to screening

排除标准

  • Participants who meet ANY of the following criteria will not be eligible for participation in this study.
  • History of seizure disorder or any condition leading to an increased risk of seizure
  • Significant neurological disorder or brain trauma
  • Presence of internal metal objects in the head, either implanted or result of shrapnel injury, that would be considered unsafe for MRI (dental work is not an exclusion)
  • Any implanted medical devices with electronic components (e.g.: pacemaker, neural stimulator)
  • Current severe or uncontrolled substance use as assessed by study psychiatrist interview at screening
  • Any unstable or poorly managed significant medical condition
  • Females who are pregnant or currently breastfeeding, or who are not using effective contraception.
  • Participation in any other clinical intervention trial from baseline to the Week 8 follow-up
  • Comorbid psychotic/delusional disorders or any psychiatric disorder that would prevent patient from attending treatment schedule
  • Severe behavioural disturbances such that they would be unable to comply with the requirements of informed consent or comply with the study protocol

研究者

发起方
Orygen

相似试验