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临床试验/NCT01514435
NCT01514435已完成不适用

Clinical Effects of Electroconvulsive Therapy in Severe Depression and Concomitant Changes in Cerebral Glucose Metabolism - an Exploratory Study

Medical University of Graz2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2006年5月1日最近更新:
适应症
干预措施

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

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

Experimental

Patients with treatment refractory depression treated with ECT

干预措施: Electroconvulsive therapy (Device)

ECT verum group

Experimental

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

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (2)

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