6/8-Prolonging Remission in Depressed Elderly (PRIDE)

6/8-延长抑郁老年人的缓解期（PRIDE）

• 批准号: 8240511
• 负责人: Mustafa M. Husain
• 金额: $ 20.38万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 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 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8240511
• 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; 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.

虽然在老年抑郁症的急性治疗方面取得了进展，但在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，抗抑郁反应的丧失可导致持续的功能障碍和自杀风险增加。这对于严重和/或治疗抵抗性疾病尤其突出，即使在成功的ECT之后。这种竞争性的持续应用建立在我们先前的工作基础上，表明持续药物治疗和持续ECT在6个月内同样有效，但仅适度有效。这些结果强调了需要开发改进的策略来维持缓解和优化功能结果。目前的申请测试了一种新的策略，在急性期利用药物治疗增强ECT。然后，它结合了2种延续模式[药物治疗和延续ECT]，并引入了一种新的以患者为中心的个性化ECT计划（症状滴定，基于症状的纵向ECT（稳定）），以提高老年抑郁症的长期结局。在STABLE中，ECT方案是临床驱动的，以防止对不需要的患者进行过度治疗，并允许重新捕获那些可能在严格给药方案下复发的患者的临床应答。STABLE结合了固定的ECT减量，然后是针对症状再次出现的个性化、灵活的ECT时间表。这一方法为实地如何进行连续ECT提供了第一个可操作的指导。老年抑郁症延长缓解（PRIDE）试验的主要目的是在老年抑郁症患者的随机临床试验中比较两种策略的相对疗效、功能结局和耐受性，以在成功的急性治疗后维持抗抑郁作用：1）文拉法辛和锂的联合药物治疗（PHARM）和2）相同的药物治疗联合三次滴定ECT（稳定）。在7个研究中心，322名患者接受了标准化药物增强的ECT急性过程（第1阶段）; 188名缓解者被随机分配到2组之一，并随访6个月（第2阶段）。主要结局指标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指标。