CONTINUATION ECT VS PHARMACOTHERAPY--EFFICACY AND SAFETY

描述(由申请人提供)：这是一份竞争性续签申请 寻求两年的额外资金，以完成正在进行的多站点 研究，“持续ECT与药物治疗。”这项研究的目标是 持续ECT与积极联合药物治疗的比较 去甲替林加锂预防抑郁症复发的策略 在成功的电击治疗重度抑郁症后。截至2001年5月30日，我们有 成功将470名患者纳入研究的急性ECT阶段(阶段 I)和159名患者进入两个治疗组的随机阶段(II阶段)。 这相当于必要的招聘目标的73%。一项额外的 56名随机患者将被纳入以达到目标随机样本 大小为216。完成患者招募、随访和分析 结果可以在本文件中要求的额外24个月内完成 申请。电休克疗法(ECT)是一种非常有效的治疗方法 治疗重度抑郁障碍(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， 尽管常规药物治疗，ECT后的复发率高得惊人 (C-医药)。持续ECT(C-ECT)也在临床上得到广泛应用， 然而，它的有效性和安全性从未经过严格的测试。的作用 C-ECT在危重MDD急症患者预防复发中的应用 待定。正在进行的研究是一项前瞻性的、为期六个月的随机研究 在临床试验中，MDD患者的急性病程缓解 双侧ECT被随机分配到两个治疗组之一：C-Pharm (去甲替林+锂)或C-ECT。主要的假设是C-ECT将 比C-Pharm更有效地预防复发。两种延续疗法 还将比较它们对认知表现的影响，全球 功能、副作用和感知的健康状况。研究设计特点 包括严格的汇款标准，盲目的神经心理评估， 严格的质量控制程序，包括独立、盲目评级 录制了汉密尔顿抑郁评定量表和SCID访谈，以及 对数据收集和分析进行独立监督。完成后，这 该项目将提供关于C-ECT在以下方面作用的第一个和明确的数据 严重情感性疾病的治疗。

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 versus Pharmacotherapy." 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.