Comparative Efficacy and Cognitive Side-Effects of Ultrabrief Right Unilateral Electroconvulsive Therapy and Brief Pulse Bitemporal Electroconvulsive Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Hamilton Depression Rating Scale (HAMD)
研究概览
简要总结
To evaluate the equivalent efficacy of ultrabrief pulsewidth right unilateral electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy in the treatment of depression and to evaluate the cognitive effects of ultrabrief right unilateral electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy.
详细描述
Patients will be randomized to either bitemporal brief pulse electroconvulsive therapy ( 0.5 ms pulse width) or right unilateral ultrabrief pulse electroconvulsive therapy for the first six treatments. If further treatment is necessary, electrode placement will be chosen by the treating psychiatrist. All electroconvulsive therapy treatments will be performed with a Thymatron System IV instrument. (Somatics, LLC, Lake Bluff, Illinois, USA) Pre- electroconvulsive therapy testing will occur within one week of beginning treatment. Post-electroconvulsive therapy testing will occur within 48 hours of the 6th treatment.
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
- •All patients age 18 and above referred for electroconvulsive therapy will be screened for eligibility for participation in this study.
- •Basic competency in English
- •Diagnosis of either of the following:
- •Major Depressive Disorder, Single Episode
- •Major Depressive Disorder, Recurrent
- •Bipolar Disorder, Currently Depressed
排除标准
- •Pre-existing cognitive impairment with an initial Mini Mental Status Exam Score of 24 or lower
- •Major neurological disease
- •Other medical conditions making electroconvulsive therapy an excessive risk to be completed safely in an outpatient surgery center and anticonvulsant therapy.
- •Pregnancy
结局指标
主要结局
Hamilton Depression Rating Scale (HAMD)
时间窗: up to 2-3 weeks
Standardized assessment administered by a psychologist
次要结局
- Mini Mental Status Examination(up to 2-3 weeks)