OPTIMIZATION OF ELECTROCONVULSIVE THERAPY

电休克治疗的优化

• 批准号: 6499375
• 负责人: HAROLD A. SACKEIM
• 金额: $ 21.41万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-02-01 至 2006-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6499375
• 关键词: antidepressants; behavioral /social science research tag; blood tests; clinical research; clinical trial phase I; cognition disorders; combination therapy; dosage; electrical potential; electroconvulsive therapy; electrodes; electroencephalography; human subject; human therapy evaluation; iatrogenic disease; lithium; major depression; memory disorders; mental disorder chemotherapy; nortriptyline; relapse /recurrence

DESCRIPTION: (Adapted from Applicant's Abstract): Patients treated with electroconvulsive therapy typically present with the most severe forms of major depression. Likely due to the increasing representation of medication-resistant patients, ECT response rates have diminished relative to earlier decades. This diminished response rate and early relapse following response are critical clinical problems in the use of ECT. Using the CSMD mechanism, this project addresses two key issues in the optimization of ECT in patients with major depression: whether patients treated with ECT should receive concurrent treatment with antidepressant medications (to enhance ECT outcome and/or prevent early relapse) and the role of electrode placement (high dosage right unilateral (RUL) ECT versus low dosage bilateral (BL) ECT) in maximizing short-term response and minimizing side effects. Patient enrollment, treatment, and evaluation will be conducted at Wake Forest University, Washington University, and the Western Psychiatric Institute and Clinic, with staff at the New York State Psychiatric Institute responsible for study coordination and monitoring. The study uses a random assignment, double-masked, parallel group design with two phases. In Phase 1, stratified by the classification of medication resistance, patients are randomized to concurrent treatment with nortriptyline (NT, n=210], venlafaxine (VEN, n=210) or placebo (PL, n=210), and simultaneously to high dosage (6 times threshold) RUL ECT (n=315) or low dosage (1.5 times threshold) BL ECT (n=315). Based on substantial preliminary data, the hypotheses will be tested that (1) compared to PL, concurrent NT or VEN results in superior symptomatic response, without a meaningful difference in side effects, and (2) RUL and BL ECT are equal in efficacy, but with significant advantages to high dosage RUL ECT in the magnitude of short- and long-term cognitive side effects. Support for these hypotheses in a large and diverse sample should have widespread ramifications for clinical practice. In the Phase 2 double-masked, 6-month continuation trial, remitters who received PL during ECT are randomized to NT and lithium (LI) or to VEN-LI. Patients who had been randomized to concurrent NT or VEN during ECT receive continuation treatment with NT-LI or VEN-LI, respectively. Standard practice involves the discontinuation of antidepressant medications prior to ECT, the abrupt discontinuation of ECT upon response, and then a switch to continuation pharmacotherapy. This practice likely diminishes response to ECT and heightens relapse in the first several weeks following ECT. Phase 2 of this study, centering on the comparison of patients treated with an antidepressant medication (NT or VEN) or placebo during ECT, will provide the very first data on whether starting an antidepressant medication from the beginning of the ECT course reduces the rate of early relapse.

描述：(改编自申请者摘要)：患者接受 电休克治疗通常表现为最严重的主要形式的 抑郁症。可能是因为耐药的人越来越多 与前几十年相比，ECT应答率有所下降。这 应答率降低和应答后早期复发是关键 ECT使用中的临床问题。使用CSMD机制，该项目 解决了优化重症患者ECT的两个关键问题 抑郁症：接受ECT治疗的患者是否应该同时接受 使用抗抑郁药物治疗(以提高ECT结果和/或 防止早期复发)和电极放置的作用(高剂量右 单侧(RUL)ECT与小剂量双侧(BL)ECT的最大化比较 短期反应，将副作用降至最低。病人登记，治疗， 评估将在华盛顿维克森林大学进行 大学和西方精神病研究所和诊所，工作人员在 纽约州精神病研究所负责研究协调和 监控。这项研究采用随机分配、双掩码、平行组 设计分两个阶段进行。在阶段1中，按以下分类分层 药物耐药，患者随机接受同时治疗 去甲替林(NT，n=210)、文拉法辛(VEN，n=210)或安慰剂(PL，n=210)，以及 同时给予高剂量(6倍阈值)RUL ECT(n=315)或低剂量 (1.5倍阈值)BLECT(n=315)。根据大量的初步数据， 将检验以下假设：(1)与PL、并发NT或VEN相比 导致更好的症状反应，而没有显著差异 副作用，以及(2)RUL和BLECT的疗效相同，但 高剂量RUL ECT在短波和短波量级上的显著优势 长期的认知副作用。对这些假说的支持在很大程度上 多样化的样本应该对临床实践产生广泛的影响。在……里面 第二阶段双掩蔽，6个月继续试验，汇款者收到 ECT期间的PL被随机分为NT和锂(Li)或VEN-Li。患者 在ECT接收继续期间被随机分为并发NT或VEN 分别用NT-LI或VEN-LI治疗。标准实践涉及 ECT前停用抗抑郁药，突发性 响应后停止ECT，然后切换到继续 药物疗法。这种做法可能会降低对ECT的反应，并增强 在电疗后的头几周内复发。这项研究的第二阶段 中心是对接受抗抑郁药物治疗的患者进行比较 ECT期间的药物(NT或VEN)或安慰剂将提供第一批数据 关于是否从ECT开始就开始服用抗抑郁药 疗程可降低早期复发率。