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，经常接受这种方式的患者 出现严重的重度抑郁症。早期复发也许是 ECT使用中最关键的临床问题。在单极 患者，当前标准是使用持续单一疗法 用于预防复发的杂环（HCA）或其他抗抑郁药 遵循ECT。这种做法主要基于进行的三项研究 1960年代在英国。除了方法论缺陷外， 这项工作要进行实践是值得怀疑的。 ECT经常是 “第一选择”治疗和适当药物治疗的标准 发生了很大变化。抵抗抗抑郁药的适当试验 现在是ECT和同一类的主要指标 抗抑郁药在急性发作期间患者失败 通常用作ECT后的持续治疗。的功效 这种做法从未得到证实。在早期的自然主义 研究，我们发现，患者的复发率是 与患者相比 谁在没有任何适当的药物试验的情况下来了。足够的 Postect药物治疗仅与复发有关。在 相关研究，我们还建议抗药性是 ECT短期结局的有力预测指标。使用R10机制， 我们建议完成一项多中心研究，以重新评估 ECT反应者中的连续药物疗法。该研究进行了 在爱荷华大学的纽约州精神病学研究所和 西方精神病学研究所和诊所。平行组，随机 分配，双盲设计用于测试相对功效 安慰剂，氯替林和组合诺特林线lithium 在ECT反应后，碳酸盐处理以防止复发 原发性单极患者。从一开始就假设 仅诺替林林对许多患者的好处有限，而更少 比与锂的组合有效。临时数据文档 安慰剂和氯蒂林的复发率都非常高，以及 联合处理的实质性功效。另外，一个较大的 对临床特征和 治疗史，以及ECT给药的标准化 站点。该假设测试了药物抗药性是有效的 ECT疗效的预测指标，并在考虑时是负责的 抑郁症患者的明显相关性明显 精神病。这项研究应该对ECT何时具有重要意义 在治疗急性抑郁发作期间考虑的，大多数 至关重要的是，建立有效的药理学策略 预防复发。