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临床试验/NCT00069407
NCT00069407已完成不适用

Comparing Three Electrode Placements to Optimize ECT

University of Medicine and Dentistry of New Jersey4 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2003年2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
入组人数
230
试验地点
4
主要终点
Hamilton Depression Rating Scale, 24 item

研究概览

简要总结

This study will compare the antidepressant benefits and cognitive side effects of three different types of electroconvulsive therapy (ECT) in people with unipolar or bipolar depression.

详细描述

ECT is an important treatment for severely depressed people who do not respond adequately to, or are intolerant of, antidepressant medication. Traditionally, ECT has been administered with one of two standard techniques: bilateral and right unilateral electrode placement. However, these techniques are limited by either low efficacy or high cognitive impairment. Recently, an additional technique for ECT administration has shown promise in preliminary studies: bifrontal ECT. This study will compare this technique to the two traditional ECT techniques in treating people with depressive symptoms.

Participants in this study will be randomly assigned to receive standard bilateral ECT, high-dose right unilateral ECT, or bifrontal ECT in their index course. Depression symptoms, neuropsychological status, and quality of life will be measured throughout the course of the ECT treatment, one week after, and at a 2-month follow-up visit. This study will run for 4 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • •Diagnosis of unipolar or bipolar depression

排除标准

  • 未提供

研究组 & 干预措施

RUL

Active Comparator

Right unilateral electroconvulsive therapy

干预措施: Electroconvulsive Therapy (Procedure)

BL

Active Comparator

Bilateral electroconvulsive therapy

干预措施: Electroconvulsive Therapy (Procedure)

BF

Active Comparator

Bifrontal electroconvulsive therapy

干预措施: Electroconvulsive Therapy (Procedure)

结局指标

主要结局

Hamilton Depression Rating Scale, 24 item

时间窗: 4 weeks

Depression symptom rating

次要结局

  • Neuropsychological assessment(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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