Comparing Three Electrode Placements to Optimize ECT

描述（由申请人提供）：对于对抗抑郁药物反应不充分或不耐受的严重抑郁症患者，电休克疗法仍然是一种重要的治疗方法。随着重度抑郁症患病率的增加，特别是在老年人群中，对有效治疗的需求是一个紧迫的公共卫生问题。尽管技术有了改进，但与ECT相关的认知损伤仍然是许多患者严重关注的问题。传统上，ECT有两种标准技术：1)双侧（双颞）电极放置或2)右侧单侧电极放置。双侧电极放置效果更好，但造成的认知障碍更大，而右侧单侧电极放置对部分患者效果较差，但造成的认知障碍较小。最近，两种创新技术在初步研究中显示出希望：1)以更高的电剂量施用右侧单侧ECT，可能达到与双侧ECT相当的疗效；2)一种新的电极放置（双正面），可能结合双侧和单侧ECT的有益特性。

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.