CONTINUATION PHARMACOTHERAPY FOLLOWING ECT

ECT 后继续药物治疗

• 批准号: 2890927
• 负责人: HAROLD A. SACKEIM
• 金额: $ 8.4万
• 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: 1997
• 资助国家: 美国
• 起止时间: 1997-04-01 至 2001-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2890927
• 关键词: behavioral /social science research tag; clinical depression; clinical research; clinical trials; combination chemotherapy; combination therapy; electroconvulsive therapy; human subject; human therapy evaluation; lithium; mental disorder chemotherapy; mental disorder prevention; nortriptyline; relapse /recurrence

ECT is highly effective and patients that receive this modality often present with severe forms of major depression. Early relapse is perhaps the most critical clinical problem in the use of ECT. In unipolar patients, the current standard is to use continuation monotherapy with a heterocyclic (HCA) or other antidepressant for relapse prevention following ECT. This practice is largely based on three studies conducted in England in the 1960's. Besides methodological flaws, the relevance of this work to present practice is questionable. ECT was frequently a 'first-choice' treatment and standards for adequate pharmacotherapy have changed considerably. Resistance to adequate trials of antidepressants is now the primary indication for ECT and the same class of antidepressant medication that patients failed during the acute episode is commonly used as continuation therapy following ECT. The efficacy of this practice has never been substantiated. In an earlier naturalistic study, we found that the relapse rate was twice as high in patients who had failed one or more adequate preECT HCA trials, compared to patients who came to ECT without any adequate medication trials. Adequacy of postECT pharmacotherapy was only marginally related to relapse. In related research, we have also suggested that medication resistance is a strong predictor of ECT short-term outcome. Using the R10 mechanism, we propose to complete a multi-center study that re-evaluates continuation pharmacotherapy in ECT responders. The study is conducted at the New York State Psychiatric Institute, University of Iowa, and Western Psychiatric Institute and Clinic. A parallel group, random assignment, double-blind design is used to test the relative efficacies of placebo, nortriptyline, and combination nortriptyline-lithium carbonate treatments in preventing relapse following ECT response in primary unipolar patients. It was hypothesized at the outset that nortriptyline alone was of limited benefit for many patients and less effective than its combination with lithium. The interim data document remarkably high relapse rates both with placebo and nortriptyline, and substantial efficacy for the combination treatment. In addition, a larger sample is prospectively evaluated regarding clinical features and treatment history, with standardization of ECT administration across sites. The hypothesis is tested that medication resistance is a potent predictor of ECT efficacy, and, when considered, is responsible for the apparent association of better ECT response in depressed patients with psychosis. This study should have important implications for when ECT is considered during the treatment of the acute depressive episode and, most critically, in establishing an efficacious pharmacological strategy for relapse prevention.

ECT非常有效，接受这种方式的患者通常 患有严重的抑郁症早期复发可能是 ECT使用中最关键的临床问题。以单极 患者，目前的标准是使用持续单药治疗， 用于预防复发的杂环（HCA）或其他抗抑郁药 ECT之后。这一做法主要基于三项研究， 1960年代的英国。除了方法上的缺陷， 这项工作目前的做法是值得怀疑的。ECT通常是一种 “首选”治疗和适当药物治疗的标准 变化很大。抗抑郁药充分试验的抗性 现在是ECT的主要适应症， 患者在急性发作期间失败的抗抑郁药物 通常用作ECT后的延续治疗。的疗效 这种做法从未得到证实。在早期的自然主义 在一项研究中，我们发现， 与患者相比， 在没有充分的药物试验的情况下接受电休克疗法。足够 ECT后药物治疗与复发仅轻微相关。在 相关研究表明，药物耐药性是 ECT短期结果的强预测因素。使用R10机制， 我们建议完成一项多中心研究， ECT应答者的持续药物治疗。开展研究 在纽约州立精神病研究所，爱荷华州大学， 西方精神病研究所和诊所。平行组，随机的 分配，采用双盲设计检验相对疗效 安慰剂、去甲替林和去甲替林-锂联合给药 碳酸盐治疗在预防ECT应答后复发中的作用 原发性单极患者一开始就假设， 单用去甲替林对许多患者的益处有限， 比它与锂的组合更有效。临时数据文件 安慰剂和去甲替林的复发率都非常高， 联合治疗的显著疗效。此外，更大的 前瞻性评价样本的临床特征， 治疗史，ECT给药标准化， 网站.该假设是测试，药物耐药性是一个强大的 ECT疗效的预测因子，并且，当考虑时，负责 抑郁症患者的ECT反应较好， 精神病这项研究应该对ECT何时使用具有重要意义。 在急性抑郁发作的治疗过程中， 关键是，在建立有效的药理学策略， 预防复发