CONTINUATION ECT VS PHARMACOTHERAPY--EFFICACY AND SAFETY

描述（申请人摘要）：电休克治疗（ECT）是一种 重度抑郁症（MDD）的高效治疗，即 对患有最严重的情感疾病的患者有帮助。 成功的急性期ECT或药物治疗后复发仍然是一个主要的 公共卫生问题。 为了防止患有MDD的患者复发， 对ECT有反应，通常的做法是开抗抑郁药 (e.g.,三环类（TCA），选择性5-羟色胺再摄取抑制剂（SSRI）， 或锂），作为持续治疗。 最近的研究显示， 尽管常规继续治疗，ECT后复发率仍较高 药物治疗（C-PHARM）。 连续ECT（C-ECT）也广泛应用于 然而，临床使用中，其有效性和安全性从未受到严格的限制。 测试. C-ECT在预防重症患者复发中的作用 因此，MDD迫切需要定义。 目前，没有任何信息 C-ECT的相对有效性和安全性， 传统的C-PHARM方法。 在一项为期6个月的前瞻性随机单盲试验中，我们将比较 积极的药理学策略的相对功效 [去甲替林和锂的组合，（NOR-Li）]和C-ECT， 预防对ECT有反应的MDD患者复发。 的 一个主要的假设是，C-ECT将更有效地防止复发， C-PHARM。4个研究中心的研究者（马约诊所，南卡罗来纳医科大学，SUNY Stony 布鲁克和德克萨斯大学西南医学中心达拉斯）将随机分配228名患者 超过4年。每个研究中心的评估者将评估症状和副作用。 根据定期获得的经过编辑的录像带， 独立于研究中心的盲态评价者也将评估症状。 一 在急性期ECT之前进行神经心理成套检查， ECT疗程后不久，急性期结束后3个月 治疗结束时，以及6个月的持续试验结束时。 这些 将比较持续治疗对复发的影响， 认知表现、整体功能、副作用和感知 健康状况。 NOR和Li水平将根据血液水平进行优化 监测. 双侧ECT，间隔逐渐增加， 用于C-ECT。 包括方法以确保临床的完整性 诊断、症状严重程度评估、数据收集和录入，以及 治疗实施 在所有患者中， 康乐药物会透过尿液测试来监察。 这次调查 是第一个比较疗效和安全性的对照研究， C-ECT和C-PHARM，并可能对临床护理产生相当大的影响， MDD患者

DESCRIPTION (Applicant's abstract): Electroconvulsive therapy (ECT) is a highly effective treatment for major depressive disorder (MDD), that is helpful for patients with the most severe forms of affective illness. Relapse after successful acute phase ECT or pharmacotherapy remains a major public health problem. To prevent relapse in patients with MDD who have responded to ECT, the common practice is to prescribe an antidepressant (e.g., a tricyclic (TCA), a selective serotonin reuptake inhibitor (SSRI), or lithium), as continuation therapy. Recent studies show an alarmingly high relapse rate after ECT despite conventional continuation pharmacotherapy (C-PHARM). Continuation ECT (C-ECT) is also in widespread clinical use, however, its efficacy and safety have never been rigorously tested. The role of C-ECT in relapse prevention of seriously ill patients with MDD urgently needs to be defined. Currently, there is no information on the relative efficacy and safety of C-ECT in comparison to the traditional approach of C-PHARM. In a prospective, 6-month, randomized, single-blind trial, we will compare the relative efficacy of an aggressive pharmacological strategy [nortriptyline and lithium in combination, (NOR-Li)] and C-ECT in the prevention of relapse in patients with MDD who have responded to ECT. The major hypothesis is that C-ECT will more effectively prevent relapse than C-PHARM. Investigators at 4 sites (Mayo Clinic, Med Univ of SC, SUNY Stony Brook, and Univ of Texas SW Med Center Dallas) will randomize 228 patients over 4 yrs. Raters at each site will evaluate symptoms and side effects. On the basis of edited videotapes obtained at regular intervals, a site-independent, blinded evaluator also will assess symptoms. A neuropsychological battery will be administered prior to acute phase ECT, shortly after the ECT course, 3-months after the end of acute phase treatment, and at the end of the 6-month continuation trial. These continuation therapies will be compared in their effects on relapse, cognitive performance, global functioning, side effects, and perceived health status. NOR and Li levels will be optimized by blood level monitoring. Bilateral ECT, at progressively increasing intervals, will be used for C-ECT. Methods are included to ensure the integrity of clinical diagnoses, symptom severity assessment, data collection and entry, and treatment delivery. In all patients, surreptitious use of prescription or recreational drugs will be monitored by urine testing. This investigation is the first controlled study of the comparative efficacy and safety of C-ECT and C-PHARM, and may have considerable impact on the clinical care of patients with MDD.