Comparing Three Electrode Placements to Optimize ECT

比较三种电极放置以优化 ECT

• 批准号: 6754364
• 负责人: Mustafa M. Husain
• 金额: $ 19.29万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-16 至 2006-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6754364
• 关键词: adult human (21+); clinical research; clinical trials; cognition; cooperative study; dosage; electroconvulsive therapy; electrodes; human subject; human therapy evaluation; longitudinal human study; major depression; neuropsychological tests; patient oriented research; quality of life; technology /technique development; therapy adverse effect

DESCRIPTION (provided by applicant): Electroconvulsive therapy remains an important treatment for severely depressed patients who do not respond adequately to, or are intolerant of, antidepressant medication. As the prevalence of major depression increases, particularly in the geriatric population, the need for effective treatments is an urgent public health concern. Despite refinements in technique, the cognitive impairment associated with ECT remains a serious concern for many patients. Traditionally, ECT has been administered with one of two standard techniques: 1) bilateral (bitemporal) electrode placement or 2) right unilateral electrode placement. Bilateral electrode placement has greater efficacy but causes more cognitive impairment, while right unilateral electrode placement is less effective for some patients but causes less cognitive impairment. Recently, two innovative techniques have shown promise in preliminary studies: 1) right unilateral ECT administered at much higher electrical dose, which may achieve efficacy equivalent to bilateral ECT and 2) a novel electrode placement (bifrontal) which may combine the beneficial properties of both bilateral and unilateral ECT. We propose a double blind, randomized, controlled clinical trial comparing the standard technique of bilateral ECT with two novel techniques - high-dose unilateral ECT and bifrontal ECT. The primary aims of the study are to compare the three treatments in terms of 1) antidepressant efficacy and 2) cognitive effects during and at the end of the treatment course, and over a two-month naturalistic follow-up period. An additional aim is to compare the treatments in terms of quality of life over two months. In this study, 360 patients with major depression are randomized over 4 years at 4 sites. Assessments are the Hamilton Rating Scale for Depression (HRSD), a comprehensive neuropsychological test battery, and quality of life outcome measures. Provisions are made for assuring the ongoing quality of treatments and assessments. The investigators are experienced ECT providers and researchers who are now successfully collaborating on an ongoing NIMH-funded trial of continuation ECT vs. pharmacotherapy. The proposed study will be the first direct comparison of the three types of ECT and will inform psychiatrists about the optimal technique of ECT. The results of this study will promote more effective and safer treatment of the most severely ill depressed patients.

描述(申请人提供)：电休克治疗仍然是严重抑郁症患者的一种重要治疗方法，这些患者对抗抑郁药物没有足够的反应或不能耐受。随着严重抑郁症患病率的增加，特别是在老年人口中，有效治疗的需要是一个紧迫的公共卫生问题。尽管在技术上有所改进，但与ECT相关的认知障碍仍然是许多患者的严重担忧。传统上，ECT采用两种标准技术之一：1)双侧(双侧)电极放置或2)右侧单侧电极放置。双侧电极放置效果较好，但会导致更多的认知损害，而右侧电极放置对一些患者效果较差，但导致较少的认知损害。最近，两种创新技术在初步研究中显示出了希望：1)以更高的电剂量进行右侧ECT，其疗效可能与双侧ECT相当；2)一种新的电极放置(双正交)，可以结合双侧和单侧ECT的有益特性。 我们提出了一项双盲、随机、对照的临床试验，将双侧ECT的标准技术与两种新技术--高剂量单侧ECT和双侧ECT进行比较。这项研究的主要目的是从1)抗抑郁疗效和2)治疗过程中和结束时的认知效果以及在两个月的自然随访期内对这三种治疗进行比较。另一个目的是比较两种治疗方法在两个月内的生活质量。 在这项研究中，360名患有重度抑郁症的患者在4个地点被随机分为4组。评估是汉密尔顿抑郁量表(HRSD)，一个全面的神经心理学测试组合，以及生活质量结果测量。为确保持续的治疗和评估质量作出了规定。研究人员是经验丰富的ECT提供者和研究人员，他们现在正在成功地合作进行一项由NIMH资助的持续ECT与药物治疗的试验。 这项拟议的研究将是三种类型的ECT的第一次直接比较，并将向精神病学家介绍ECT的最佳技术。这项研究的结果将促进对最严重的抑郁症患者进行更有效和更安全的治疗。