Blood Biomarkers in Electroconvulsive Therapy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in levels of blood biomarkers
研究概览
简要总结
The present multi-disciplinary study will assess blood biomarkers to investigate putative mechanisms of action of ECT. Laboratory findings will be correlated to clinical parameters, cognitive measures and psychometric outcome measures. The aim is to elucidate the underlying mechanisms for both treatment effects and cognitive side effects of ECT.
详细描述
Study hypothesis That a combined dataset of biomarker and clinical/ demographic data can be used to identify possible mechanisms of action for ECT or pathophysiological mechanisms underlying major depression.
The study is based on already (prospectively, observational) collected data and biological material:
- in the Regional ECT Register (Regionalt medisinsk kvalitetsregister for nevrostimulerende behandling i Helse Vest, Datatilsynets konsesjon 2012/5490),
- the ECT-MRI study approved by REK sørøst "2013/1032 ECT and neuroradiology" with its study specific biobank (Imdep)
- and the ECT biobank, (Forskningsbiobanken for nevrostimulerende behandling i Helse Vest (REK Vest 2017/925).
Biological samples and demographic/clinical data from those sources will be analyzed together.
All patients received the standard ECT treatment, as it is provided at the ECT-department at the Haukeland University Hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (age > 18) referred to the ECT-unit and accepted for treatment.
排除标准
- •Patients unable to give informed consent
结局指标
主要结局
change in levels of blood biomarkers
时间窗: 6 months
次要结局
未报告次要终点