Comparing Three Electrode Placements to Optimize ECT
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
Right unilateral electroconvulsive therapy
干预措施: Electroconvulsive Therapy (Procedure)
BL
Bilateral electroconvulsive therapy
干预措施: Electroconvulsive Therapy (Procedure)
BF
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)
