CONTINUATION ECT VS PHARMACOTHERAPY--EFFICACY AND SAFETY

描述(申请人摘要)：电休克治疗(ECT)是一种 对严重抑郁障碍(MDD)的高效治疗，即 对患有最严重的情感性疾病的患者很有帮助。 急性期ECT或药物治疗成功后复发仍是主要原因 公共卫生问题。防止患有MDD的患者复发 对于ECT，通常的做法是开一种抗抑郁药 (例如，三环(TCA)，选择性5-羟色胺再摄取抑制剂(SSRI)， 或锂)，作为持续治疗。最近的研究表明，令人震惊的是 尽管常规继续治疗，ECT后的高复发率 药物治疗(C-Pharm)。继续ECT(C-ECT)也很普遍 然而，其临床应用的有效性和安全性从未得到严格的验证。 测试过。C-ECT在危重病人预防复发中的作用 对于MDD，迫切需要定义。目前，没有任何信息 C-ECT相对有效性和安全性的比较研究 传统的C-Pharm方法。 在一项为期6个月的前瞻性、随机、单盲试验中，我们将比较 侵袭性药物治疗策略的相对有效性 [去甲替林和锂联合，(Nor-Li)]和C-ECT在 预防经ECT治疗有效的MDD患者复发。这个 主要的假设是C-ECT将比C-ECT更有效地预防复发 C-辉瑞。4个地点(梅奥诊所、南加州大学医学院、纽约州立大学石碑分校)的调查人员 Brook和德克萨斯大学西南医学中心达拉斯分校)将随机选择228名患者 四年多了。每个站点的评分员将评估症状和副作用。 根据定期获得的经过编辑的录像带， 独立于现场、盲目的评估者也将评估症状。一个 在急性期电击治疗前会进行神经心理测试， ECT疗程结束后不久，急性期结束后3个月 治疗，并在6个月的持续试验结束时。这些 继续治疗将在它们对复发的影响方面进行比较， 认知表现、全球功能、副作用和知觉 健康状况。NOR和Li水平将根据血液水平进行优化 监控。双边电击治疗将以逐渐增加的间隔进行 用于C-ECT。包括确保临床的完整性的方法 诊断、症状严重性评估、数据收集和录入，以及 治疗递送。在所有患者中，秘密使用处方药或 娱乐毒品将通过尿液检测进行监测。这项调查 是首个比较有效率和安全性的对照研究 C-ECT和C-Pharm，并可能对临床治疗产生相当大的影响 MDD患者。

DESCRIPTION (Applicant's abstract): Electroconvulsive therapy (ECT) is a highly effective treatment for major depressive disorder (MDD), that is helpful for patients with the most severe forms of affective illness. Relapse after successful acute phase ECT or pharmacotherapy remains a major public health problem. To prevent relapse in patients with MDD who have responded to ECT, the common practice is to prescribe an antidepressant (e.g., a tricyclic (TCA), a selective serotonin reuptake inhibitor (SSRI), or lithium), as continuation therapy. Recent studies show an alarmingly high relapse rate after ECT despite conventional continuation pharmacotherapy (C-PHARM). Continuation ECT (C-ECT) is also in widespread clinical use, however, its efficacy and safety have never been rigorously tested. The role of C-ECT in relapse prevention of seriously ill patients with MDD urgently needs to be defined. Currently, there is no information on the relative efficacy and safety of C-ECT in comparison to the traditional approach of C-PHARM. In a prospective, 6-month, randomized, single-blind trial, we will compare the relative efficacy of an aggressive pharmacological strategy [nortriptyline and lithium in combination, (NOR-Li)] and C-ECT in the prevention of relapse in patients with MDD who have responded to ECT. The major hypothesis is that C-ECT will more effectively prevent relapse than C-PHARM. Investigators at 4 sites (Mayo Clinic, Med Univ of SC, SUNY Stony Brook, and Univ of Texas SW Med Center Dallas) will randomize 228 patients over 4 yrs. Raters at each site will evaluate symptoms and side effects. On the basis of edited videotapes obtained at regular intervals, a site-independent, blinded evaluator also will assess symptoms. A neuropsychological battery will be administered prior to acute phase ECT, shortly after the ECT course, 3-months after the end of acute phase treatment, and at the end of the 6-month continuation trial. These continuation therapies will be compared in their effects on relapse, cognitive performance, global functioning, side effects, and perceived health status. NOR and Li levels will be optimized by blood level monitoring. Bilateral ECT, at progressively increasing intervals, will be used for C-ECT. Methods are included to ensure the integrity of clinical diagnoses, symptom severity assessment, data collection and entry, and treatment delivery. In all patients, surreptitious use of prescription or recreational drugs will be monitored by urine testing. This investigation is the first controlled study of the comparative efficacy and safety of C-ECT and C-PHARM, and may have considerable impact on the clinical care of patients with MDD.