CONTINUATION OF PHARMACOTHERAPY FOLLOWING ECT

描述(改编自申请人的摘要)：申请人争辩 ECT是非常有效的，并注意到接受这种治疗的患者 情态障碍通常表现为严重形式的严重抑郁。早期复发 可能是ECT使用中最关键的临床问题。在……里面 单相患者，目前的标准是使用持续的单一疗法 使用杂环(HCA)或其他抗抑郁药预防复发 在电击治疗后。这种做法很大程度上是基于在 S。除了方法论上的缺陷，这一点的相关性 呈现实践的工作是值得怀疑的。ECT常常是第一个 选择“治疗”，适当药物治疗的标准发生了变化 相当可观。对足够的抗抑郁药物试验的抵抗力现在是 ECT的主要适应症，以及同类抗抑郁药物 患者在急性发作期间失败通常被用作 ECT后的继续治疗。这种做法的效果从来没有 已经被证实了。在一项早期的自然主义研究中，这些研究人员 发现失败的患者的复发率是前者的两倍 或与接受ECT治疗的患者相比，进行更充分的ECT前HCA试验 在没有任何适当药物试验的情况下。ECT治疗后的充分性 药物治疗与复发的关系不大。在相关的 研究人员还表示，药物耐药性 是ECT短期结果的有力预测指标。使用R10机制， 这三名申请者提议完成一项多中心研究， 重新评估ECT应答者的持续药物治疗。这项研究将 在纽约州精神病学研究所进行；加州大学 爱荷华州；以及西方精神病研究所和诊所。一个平行的小组， 相关检验采用随机分配、双盲设计 安慰剂、去甲替林及去甲替林锂联合用药的疗效 碳酸盐疗法预防小学生ECT反应后复发的研究 单相患者。一开始就假设去甲替林 单独对许多患者的益处有限，而且不如它的有效 与锂的结合。中期数据文件的复发率非常高 安慰剂和去甲替林的有效率和对 联合治疗。此外，预期还会有更大的样本。 根据临床特征和治疗历史进行评估，包括 跨站点ECT管理的标准化。假设是 试验表明，药物耐药性是ECT疗效的有效预测因素， 而且，当考虑到这一点时，它对更好的 抑郁症精神病患者的电刺激反应。申请人声称 这项研究应该对ECT何时进行具有重要意义 在治疗急性抑郁发作时考虑，大多数 关键的是，在建立一种有效的药物治疗策略 预防复发。

DESCRIPTION (adapted from applicant's abstract): The applicants contend that ECT is highly effective and note that 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, these investigators found that the relapse rate was twice as high in patients who had failed one or more adequate pre-ECT HCA trials, compared to patients who came to ECT without any adequate medication trials. Adequacy of post-ECT pharmacotherapy was only marginally related to relapse. In related research, the investigators have also suggested that medication resistance is a strong predictor of ECT short-term outcome. Using the R10 mechanism, the three applicants propose to complete a multi-center study that re-evaluates continuation pharmacotherapy in ECT responders. The study will be conducted at the New York State Psychiatric Institute; the 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. The applicants assert that 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.