Continuation ECT versus Pharmacotherapy

描述（由申请人提供）：这是一个竞争性续期申请 寻求两年的额外资金，以完成正在进行的多站点 研究，“继续ECT：有效性和安全性。“这项研究的目标是 比较连续ECT与积极的联合药物治疗 去甲替林加锂剂预防抑郁症复发的研究 在成功治疗重度抑郁症之后截至2001年5月30日， 成功招募了470名患者进入研究的急性ECT阶段（阶段 I）和159例患者进入两个治疗组随机化阶段（II期）。 这相当于必要征聘目标的73%。额外 将入组56例随机化患者，以满足目标随机化样本 大小216完成患者招募、随访和分析 结果可以实现与额外的24个月要求在这一点上， 应用程序.电休克治疗是一种非常有效的治疗方法 重度抑郁症（MDD）急性期ECT后复发或 药物治疗仍然是一个主要的公共卫生问题。最近的研究表明， 尽管有常规药物治疗，ECT后的复发率仍高得惊人 （C-PHARM）。连续ECT（C-ECT）也广泛用于临床， 然而，其功效和安全性从未经过严格测试。的作用 C-ECT在重度抑郁症患者复发预防中的应用 待定义。这项正在进行的研究是一项前瞻性的、为期六个月的、随机的、 在一项临床试验中， 双侧ECT随机分配至两个治疗组之一：C-PHARM （去甲替林+锂）或C-ECT。主要假设是C-ECT将 比C-PHARM更有效地预防复发。这两种持续治疗 还将比较它们对认知表现、全球 功能、副作用和感知健康状况。研究设计特征 包括严格缓解标准、盲法神经心理学评估 严格的质量控制程序，包括独立的，盲目的评级 录像汉密尔顿抑郁评定量表和SCID访谈，以及 独立监督数据收集和分析。完成后，这 该项目将提供关于C-ECT在治疗中作用的第一个和明确的数据。 治疗严重的情感疾病。

DESCRIPTION (Provided by Applicant): This is a competing renewal application seeking two years of additional funding to complete the ongoing multi-site study, "Continuation ECT: Efficacy and Safety." The goal of this research is to compare continuation ECT with an aggressive combination pharmacotherapy strategy (nortriptyline plus lithium) in the prevention of depressive relapse after successful ECT for major depression. As of May 30, 2001, we have successfully enrolled 470 patients into the acute ECT phase of the study (Phase I) and 159 patients into the two treatment arm randomized phase (Phase II). This represents 73 percent of the necessary recruitment target. An additional 56 randomized patients will be enrolled to meet the target randomized sample size of 216. Completion of patient recruitment, follow-up, and analysis of results can be accomplished with the additional 24 months requested in this application. Electroconvulsive therapy (ECT) is a highly effective treatment for major depressive disorder (MDD). Relapse after acute phase ECT or pharmacotherapy remains a major public health problem. Recent studies show an alarmingly high rate of relapse after ECT despite conventional 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. The ongoing study is a prospective, six-month, randomized clinical trial in which patients with MDD who remit with an acute course of bilateral ECT are randomized to one of two treatment arms: C-PHARM (nortriptyline + lithium) or C-ECT. The major hypothesis is that C-ECT will more effectively prevent relapse than C-PHARM. The two continuation therapies also will be compared in their effects on cognitive performance, global functioning, side effects, and perceived health status. Study design features include rigorous remitter criteria, blinded neuropsychological assessments, rigorous quality control procedures including independent, blind rating of videotaped Hamilton Depression Rating Scale and SCID interviews, and independent oversight of data collection and analysis. When completed, this project will provide the first and definitive data on the role of C-ECT in the treatment of serious affective illness.