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: 8459565
• 负责人: Mustafa M. Husain
• 金额: $ 22.18万
• 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 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8459565
• 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.

尽管在老年抑郁症的急性治疗中已经取得了进步，但成功治疗后未能维持缓解仍然是一个重大的公共卫生问题。特别是，抗抑郁反应的丧失会导致持续的功能障碍和自杀风险增加。即使在成功之后，这对于严重和/或耐药性疾病尤其重要。这种竞争性的延续申请是基于我们先前的工作，表明持续药物治疗和持续性ECT同样相同，但在6个月内的生效均无中等。这些结果突出了需要制定改进的策略以维持缓解并优化功能结果的必要性。当前的应用测试了一种新型策略，该策略在急性阶段使用药物治疗增强的ECT。然后，它结合了两种持续方式[药物疗法和持续ECT]，并引入了一种新颖的以患者为中心的ECT时间表（症状诱变，基于算法的纵向ECT（稳定）），以增强晚期抑郁症的长期结局。在稳定的情况下，ECT计划在临床上是为了防止不需要的人进行过度治疗，并允许对那些可能会因严格的剂量时间表而复发的患者重新捕捉临床反应。稳定结合了固定的ECT锥度，然后结合了一个个性化的，灵活的ECT时间表，以响应症状重新出现。这种方法为如何进行延续ECT提供了对该领域的第一个操作指导。长期缓解老年人（骄傲）试验的主要目的是在抑郁症患者的随机临床试验中进行比较，相对疗效，功能性结果以及两种策略可维持成功急性治疗后抗抑郁作用的策略：1）与静脉治疗的组合疗法（1）相同的症状（药物）和2次组合的组合 - （稳定的）。在7个部位，有322名患者接受了通过标准化药物增加的ECT急性ECT（第1阶段）；将188个汇总随机分配给2组之一，然后持续6个月（第2阶段）。主要结果指标是抑郁症的纵向连续汉密尔顿评级量表（HRSD-24）。次要结果是在老年样本中验证的功能和耐受性的度量。