Clinical Effects of Electroconvulsive Therapy in Severe Depression and Concomitant Changes in Cerebral Glucose Metabolism - an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Brain glucose metabolism measured by FDG-PET
研究概览
简要总结
There exist already a few studies that have measured changes of brain metabolism pre and post Electroconvulsive Therapy (ECT) by Positron emission tomography (PET) but these were all performed in a small number of patients and used different methodologies. It is therefore not surprising that these investigations provided inconsistent results, as reviewed previously {{23 Schmidt,E.Z. 2008}}.
In patients with treatment-refractory major depressive episodes, the investigators here therefore probed (a) whether changes in cerebral glucose metabolism measured by PET occur after treatment with ECT and (b) whether these correlate with the clinical amelioration of symptoms. To pursue this goal, the investigators assessed clinical effects, neurocognitive function, and brain metabolism using 18F-Fluoro-deoxyglucose (18F-FDG) PET at baseline and at the end of treatment.
Patients with a treatment refractory depression - defined as absent clinical improvement of depressive symptoms after at least two trials with antidepressants from different pharmacologic classes adequate in dose, duration of at least 6 weeks, and compliance {{30 Berlim,M.T. 2007}} - in whom ECT had been intended on clinical grounds were consecutively asked for participation in this study. Patients had to be between 18 and 80 years old and to be physically healthy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical indication for ECT
- •treatment refractory depressive episode
- •age 18-85 y
排除标准
- •addiction as a first diagnosis
研究组 & 干预措施
ECT verum group
Patients with treatment refractory depression treated with ECT
干预措施: Electroconvulsive therapy (Device)
ECT verum group
Patients with treatment refractory depression treated with ECT
干预措施: 18-Fluoro-desoxy-glucose positron emission tomography (Device)
结局指标
主要结局
Brain glucose metabolism measured by FDG-PET
时间窗: one year
次要结局
未报告次要终点
