7/8-Prolonging Remission in Depressed Elderly (PRIDE)

描述（由申请人提供）：虽然在老年抑郁症的急性治疗方面取得了进展，但成功治疗后未能维持缓解仍然是一个主要的公共卫生问题。特别是，丧失抗抑郁药反应可导致持续的功能损害和自杀风险增加。这对于严重和/或治疗难治性疾病尤其突出，即使在ECT成功后也是如此。这种竞争性的持续应用建立在我们之前的工作基础上，证明了持续药物治疗和持续ECT在6个月内的效果是一样的，但只有适度的效果。这些结果强调需要制定改进的策略来维持缓解和优化功能结果。目前的应用测试了一种在急性期利用药物治疗增强ECT的新策略。然后，它结合了两种持续模式[药物治疗和持续ECT]，并引入了一种新的以患者为中心的个性化ECT计划（症状滴定，基于算法的纵向ECT (STABLE)），以提高晚年抑郁症的长期疗效。在STABLE中，ECT计划是临床驱动的，以防止那些不需要它的人过度治疗，并允许那些可能因严格的给药计划而复发的患者重新获得临床反应。STABLE结合了一个固定的ECT逐渐减少，然后是一个个性化的、灵活的ECT计划，以应对症状的再次出现。这种方法为该领域如何进行持续ECT提供了第一个可操作的指导。老年抑郁症患者延长缓解期（PRIDE）试验的主要目的是在一项随机临床试验中，比较老年抑郁症患者在成功的急性治疗后，两种策略维持抗抑郁效果的相对疗效、功能结局和耐受性：1)文拉法辛和锂联合药物治疗（PHARM）和2)药物治疗加症状滴定电痉挛疗法（STABLE）。在7个地点，322名患者在标准化药物的辅助下接受了急性电痉挛治疗（第一阶段）；188名汇款人被随机分配到两组中的一组，随访6个月（第二阶段）。主要结果测量是纵向连续汉密尔顿抑郁评定量表（HRSD-24）。次要结果是在老年样本中验证的功能和耐受性的测量。预计到2020年，抑郁症将成为全球疾病负担的第二大原因，也是自杀的主要原因。鉴于老年人口的快速增长，晚年抑郁症尤为重要。以患者为中心的方法将指导制定有针对性的战略，以减轻疾病负担，并提高具有重大自杀风险的严重情绪障碍老年患者的生活质量。

DESCRIPTION (provided by applicant): While advances have been made in the acute treatment of geriatric depression, failure to maintain remission following successful treatment remains a major public health problem. In particular, loss of antidepressant response can result in ongoing functional impairment and increased risk of suicide. This is especially salient for severe and/or treatment resistant illness, even after successful ECT. This competing continuation application builds upon our prior work demonstrating that continuation pharmacotherapy and continuation ECT were equally but only modestly effective over 6 months. These results highlight the need to develop improved strategies to maintain remission and optimize functional outcomes. The current application tests a novel strategy that utilizes pharmacotherapy-enhanced ECT in the acute phase. It then combines the 2 continuation modalities [pharmacotherapy and continuation ECT], and introduces a novel patient-focused individualization of the ECT schedule (Symptom-Titrated, Algorithm-Based Longitudinal ECT (STABLE)) to enhance long-term outcomes in late-life depression. In STABLE, the ECT schedule is clinically driven to prevent over-treatment of those who do not need it, and to permit re-capturing clinical response for those patients who might have otherwise relapsed with a rigid dosing schedule. STABLE combines a fixed ECT taper followed by an individualized, flexible ECT schedule responsive to symptom re-emergence. This approach provides the first operationalized guidance to the field regarding how to conduct continuation ECT. The primary aim of the Prolonging Remission In Depressed Elderly (PRIDE) trial is to compare, in a randomized clinical trial of patients with late-life depression, the relative efficacy, functional outcomes, and tolerability of two strategies to sustain antidepressant effect after successful acute treatment: 1) combination pharmacotherapy with venlafaxine and lithium (PHARM) and 2) the same combination of pharmacotherapy plus symptom-titrated ECT (STABLE). At 7 sites, 322 patients receive an acute course of ECT augmented by standardized medication (Phase 1); 188 remitters are randomly assigned to one of the 2 groups and followed for 6 months (Phase 2). The primary outcome measure is the longitudinal continuous Hamilton Rating Scale for Depression (HRSD-24). Secondary outcomes are measures of function and tolerability validated in the geriatric sample. By 2020, depression is predicted to become the 2nd leading cause of disease burden worldwide and a major cause of suicide. Late-life depression is particularly important given the rapid growth of the geriatric segment of the population. Patient-focused approaches will guide the development of targeted strategies to reduce disease burden and to enhance quality of life for older patients with severe mood disorders who are at significant risk for suicide.