OPTIMIZATION OF ELECTROCONVULSIVE THERAPY

描述：（改编自申请人摘要）：接受以下治疗的患者 电休克治疗通常表现为最严重形式的主要 萧条可能是由于越来越多的代表性耐药 患者，ECT反应率相对于前几十年有所下降。这 缓解率降低和缓解后早期复发至关重要 使用ECT的临床问题。利用CSMD机制，本项目 解决了两个关键问题，在优化ECT患者的主要 抑郁症：接受ECT治疗的患者是否应同时接受 抗抑郁药物治疗（以增强ECT结果和/或 预防早期复发）和电极放置的作用（高剂量对 单侧（RUL）ECT与低剂量双侧（BL）ECT）在最大化 短期反应和减少副作用。患者入组、治疗， 评估将在华盛顿的维克森林大学进行 大学和西方精神病研究所和诊所，工作人员在 纽约州立精神病研究所负责研究协调， 监测.该研究采用随机分配、双盲、平行组 设计分两个阶段。在第1阶段，按照以下分类分层： 耐药性，患者随机接受以下治疗： 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 BL ECT（n=315）。根据大量的初步数据， 将检验以下假设：（1）与PL相比，同时NT或VEN 导致上级症状缓解，在以下方面无有意义的差异： 副作用，和（2）RUL和BL ECT的疗效相同，但 高剂量RUL ECT在短时间内的显著优势， 长期认知副作用。支持这些假设在一个大的， 不同的样本应该对临床实践有广泛的影响。在 II期双盲、6个月持续试验，接受治疗的缓解者 ECT期间的PL随机分为NT和锂（LI）或VEN-LI。的患者 在继续接受ECT治疗期间随机接受NT或VEN治疗 分别用NT-LI或VEN-LI治疗。标准做法包括 在ECT之前停用抗抑郁药物， 缓解后停止ECT，然后转为继续 药物治疗.这种做法可能会减少对ECT的反应， 在ECT后的前几周内复发。本研究的第二阶段， 集中在用抗抑郁药治疗的患者的比较， ECT期间的药物（NT或VEN）或安慰剂，将提供第一批数据 是否从ECT开始就开始抗抑郁药物治疗 降低早期复发率。

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.