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：（改编自申请人的摘要）：接受治疗的患者 电击疗法通常具有最严重的主要形式 沮丧。可能是由于耐药性的代表性增加 患者，相对于早期几十年来，ECT反应率降低了。这 响应率降低和反应后的早期复发至关重要 使用ECT的临床问题。使用CSMD机制，该项目 解决了主要患者ECT优化ECT的两个关键问题 抑郁：接受ECT治疗的患者是否应并发 用抗抑郁药治疗（以增强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与低剂量双侧（BL）ECT）最大化 短期反应并最大程度地减少副作用。患者入学，治疗， 评估将在华盛顿的韦克森林大学进行 大学以及西方精神病学研究所和诊所 纽约州精神病学研究所负责研究协调和 监视。该研究使用随机分配，双掩盖，平行组 具有两个阶段的设计。在第1阶段，通过分类 药物耐药性，患者被随机分配给 Nortriptyline（nt，n = 210），Venlafaxine（Ven，n = 210）或安慰剂（PL，n = 210），并且 同时至高剂量（6倍阈值）统治（n = 315）或低剂量 （阈值1.5倍）BLECT（n = 315）。基于大量初步数据 将测试假设（1）与PL，并发NT或VEN相比 导致出色的症状反应，没有有意义的差异 副作用，（2）RUL和BLECT的功效相等，但 高剂量统治的显着优势在短期和 长期认知副作用。支持这些假设 不同的样本应具有广泛的临床实践影响。在 第2阶段掩盖了6个月的连续试验，收到的汇款 ECT期间的PL被随机分为NT和锂（Li）或Ven-Li。患者 在ECT期间，已随机分配给NT或VEN 分别用NT-LI或Ven-LI处理。标准练习涉及 在ECT之前停用抗抑郁药 在响应时停止ECT，然后转换为延续 药物治疗。这种做法可能会减少对ECT的反应并增强 ECT后的前几周复发。这项研究的第2阶段， 以抗抑郁药治疗的患者的比较为中心 ECT期间的药物（NT或VEN）或安慰剂将提供第一个数据 关于从ECT开头开始抗抑郁药 课程降低了早期复发的速度。