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
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