Continuation ECT vs Pharmacotherapy: Efficacy and Safety

持续 ECT 与药物治疗：疗效和安全性

• 批准号: 6472500
• 负责人: Charles H Kellner
• 金额: $ 41.04万
• 依托单位: UNIV OF MED/DENT OF NJ-NJ MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-01 至 2004-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6472500
• 关键词: clinical research; clinical trials; cognition; combination chemotherapy; electroconvulsive therapy; functional ability; human subject; human therapy evaluation; interview; lithium; longitudinal human study; major depression; mental disorder chemotherapy; mental disorder prevention; mental health epidemiology; neuropsychological tests; nortriptyline; patient oriented research; prognosis; psychopharmacology; psychotropic drugs; quality of life; relapse /recurrence; therapy adverse effect; tricyclic antidepressant

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.

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来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 比较持续 ECT 与积极的联合药物治疗 预防抑郁症复发的策略（去甲替林加锂） ECT 成功治疗重度抑郁症后。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（Phase I) 和 159 名患者进入两个治疗组随机化阶段 (II 期)。 这占必要招聘目标的 73%。额外的 将招募 56 名随机患者以满足目标随机样本 216 的规模。完成患者招募、随访和分析 在此要求的额外 24 个月内即可取得结果 应用。电休克疗法 (ECT) 是一种高效的治疗方法 用于重度抑郁症（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 尽管采用常规药物治疗，ECT 后复发率仍高得惊人 （C-PHARM）。持续ECT（C-ECT）也在临床上广泛使用， 然而，其功效和安全性从未经过严格测试。的作用 C-ECT预防重症MDD患者复发的迫切需求 待定义。正在进行的研究是一项为期六个月的前瞻性随机研究 一项临床试验，其中患有急性病程缓解的 MDD 患者 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。两种持续疗法 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 包括严格的汇款人标准、盲法神经心理学评估、 严格的质量控制程序，包括独立、盲评 录制汉密尔顿抑郁量表和 SCID 访谈，以及 独立监督数据收集和分析。完成后，这 项目将提供关于 C-ECT 在 治疗严重的情感疾病。