2/8-Prolonging Remission in Depressed Elderly (PRIDE)

2/8-延长抑郁老年人的缓解期（PRIDE）

• 批准号: 8535868
• 负责人: Sarah H Lisanby
• 金额: $ 8.43万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-27 至 2013-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8535868
• 关键词: Academic Medical Centers; Acute; Address; Adverse event; Algorithms; Annual Reports; Antidepressive Agents; Arbitration; Attention; Case Report Form; Clinic; Clinical; Clinical Trials; Clinical Trials Design; Combination Drug Therapy; Committee Members; Conduct Clinical Trials; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Databases; Dentistry; Depressed mood; Development; Disease remission; Dose; Elderly; Elements; Ensure; Experimental Designs; Failure; Feedback; Geriatric Psychiatry; Goals; Hamilton Rating Scale for Depression; Health system; Hospitals; Housing; Human Resources; Individual; Informed Consent; Institutes; Institutional Review Boards; Joints; Leadership; Lithium; Mails; Measures; Medical; Medical center; Mental Depression; Modality; Monitor; Mood Disorders; New Jersey; New York; New York City; Older Population; Online Systems; Outcome; Outcome Measure; Participant; Patient Recruitments; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Phase; Policies; Population; Preparation; Procedures; Process; Psychiatrist; Public Health; Publications; Quality Control; Quality of life; Randomized; Randomized Clinical Trials; Regimen; Relapse; Relative (related person); Reporting; Research; Research Personnel; Resistance; Resolution; Resource Sharing; Role; SF-36; Sampling; Schedule; Secure; Signs and Symptoms; Site; Site Visit; Study Subject; Suicide; Summary Reports; Supervision; Symptoms; System; Testing; Time; Training; United States National Institutes of Health; Universities; Videoconferences; Videoconferencing; Videotape; Visit; Work; arm; authority; base; burden of illness; clinical research site; data management; data sharing; disorder later incidence prevention; flexibility; forest; functional disability; functional outcomes; geriatric depression; human subject; human subject protection; improved; medical schools; meetings; member; neuropsychological; novel; novel strategies; older patient; prevent; primary outcome; programs; quality assurance; rapid growth; response; secondary outcome; suicidal risk; symposium; treatment as usual; venlafaxine

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.

尽管老年抑郁症的急性治疗已取得进展，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，抗抑郁药反应的丧失可能导致持续的功能障碍和自杀风险增加。这对于严重和/或难治性疾病尤其重要，即使在成功进行 ECT 后也是如此。这项竞争性的延续应用建立在我们之前的工作基础上，证明延续药物治疗和延续 ECT 在 6 个月内效果相同，但效果有限。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。当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 2 种延续模式 [药物治疗和延续 ECT]，并引入了一种新颖的以患者为中心的个体化 ECT 计划（症状滴定、基于算法的纵向 ECT (STABLE)），以增强晚年的长期结果沮丧。在 STABLE 中，ECT 时间表是临床驱动的，以防止对不需要的患者进行过度治疗，并允许那些在严格的给药时间表下可能复发的患者重新获得临床反应。 STABLE 结合了固定的 ECT 逐渐减量和针对症状重新出现的个性化、灵活的 ECT 时间表。该方法为该领域提供了有关如何进行持续 ECT 的第一个可操作指南。抑郁老年人延长缓解 (PRIDE) 试验的主要目的是在一项针对晚年抑郁症患者的随机临床试验中，比较两种策略在成功急性抑郁症后维持抗抑郁效果的相对疗效、功能结果和耐受性。治疗：1）文拉法辛和锂的联合药物治疗（PHARM）和2）相同的药物治疗组合加症状滴定ECT（稳定）。在 7 个地点，322 名患者接受了 ECT 急性疗程，并辅以标准化药物治疗（第一阶段）； 188 名汇款人被随机分配到 2 组中的一组，并进行为期 6 个月的随访（第 2 阶段）。主要结果指标是纵向连续汉密尔顿抑郁量表（HRSD-24）。次要结果是在老年样本中验证的功能和耐受性测量。