Depression in Alzheimer's Disease Study-2(DIADS-2)

阿尔茨海默病中的抑郁症研究-2(DIADS-2)

• 批准号: 6792773
• 负责人: IRA R KATZ
• 金额: $ 7.7万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-18 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6792773
• 关键词: Alzheimer' s disease; caregivers; citalopram; clinical research; clinical trials; cooperative study; coping; depression; drug screening /evaluation; human subject; human therapy evaluation; longitudinal human study; mental disorder chemotherapy; neuropsychological tests; patient oriented research; pharmacokinetics; psychosocial rehabilitation; quality of life; sertraline

DESCRIPTION (provided by applicant): Depression in the context of Alzheimer's disease (AD) is a significant public health problem with serious adverse consequences for patients and their caregivers. There has been little research into the course or treatment of depression associated with AD. This is in part due to the absence of validated operational criteria for defining depression in AD. Recently, NIMH convened an expert consensus panel to develop draft criteria for depression of Alzheimer's disease (dAD) and to establish research priorities in this area. These criteria are intended to facilitate further studies of the course and treatment of depression in AD. The first aim of the proposed multicenter study is to determine whether individuals with dAD respond to antidepressant treatment using the medication sertraline in a 12-week randomized, controlled, double blind trial. The second aim is to establish whether earlier treatment of depression in AD affects critical non-mood outcomes such as cognition, quality of life, activities of daily living and caregiver variables, over 24 weeks. The third aim is to validate the dAD syndrome by evaluating its course and response to treatment in comparison to other diagnostic conceptualizations of depression in AD, over six months. These aims are consistent with priorities articulated by the NIMH expert consensus panel. 130 patients meeting criteria for dAD, and their caregivers, will be recruited into the study at five clinical centers: Johns Hopkins, University of Southern California, University of Rochester, University of Pennsylvania, and Medical University of South Carolina. The study will be coordinated by the Johns Hopkins Center for Clinical Trials. After detailed baseline characterization participants will be randomized to treatment with sertraline or placebo for at least twelve weeks and followed for up to 24 weeks. All patients and caregivers will receive psychosocial interventions for Alzheimer's and depression. Patient outcomes will include: global improvement of the depressive disturbance, ratings on a depression scale, quality of life, cognitive functioning, activities of daily living, behavioral disturbance, and adverse events. Caregiver outcomes will include: depression, quality of life, and care giving burden. Regarding the first study aim, analyses will compare the two treatment groups on patient mood outcomes in the first twelve weeks. Regarding the second study aim, analyses will compare the two treatment groups on the trajectories of patient critical AD patient outcomes (cognition, functioning, quality of life, behavior) and of caregiver outcomes over 24 weeks. Regarding the third aim, analyses will examine the longitudinal course of depressive symptoms and of depressive syndromes in the context of Alzheimer's using three different syndromic definitions: dAD, DSM-IV, and "Alzheimer's Associated Affective disorder" derived empirically. The predictive validity of defining depression in AD using a symptom scale or each of these syndromes will be assessed longitudinally against the various study outcomes, and against efficacy of response to antidepressant treatment.

描述（由申请人提供）：阿尔茨海默病 (AD) 背景下的抑郁症是一个重大的公共卫生问题，对患者及其护理人员造成严重的不利后果。关于 AD 相关抑郁症的病程或治疗的研究很少。部分原因是缺乏有效的操作标准来定义 AD 抑郁症。最近，NIMH 召集了一个专家共识小组，制定阿尔茨海默病抑郁症 (dAD) 的标准草案，并确定该领域的研究重点。这些标准旨在促进对 AD 抑郁症病程和治疗的进一步研究。拟议的多中心研究的第一个目的是在为期 12 周的随机、对照、双盲试验中确定 dAD 患者是否对使用药物舍曲林的抗抑郁治疗有反应。第二个目标是确定 AD 抑郁症的早期治疗是否会在 24 周内影响关键的非情绪结果，例如认知、生活质量、日常生活活动和照顾者变量。第三个目标是通过评估 dAD 综合征的病程和对治疗的反应，与 AD 抑郁症的其他诊断概念相比较，在六个月内验证 dAD 综合征。这些目标与 NIMH 专家共识小组阐明的优先事项一致。 130 名符合 dAD 标准的患者及其护理人员将被招募到五个临床中心参与这项研究：约翰·霍普金斯大学、南加州大学、罗切斯特大学、宾夕法尼亚大学和南卡罗来纳医科大学。该研究将由约翰霍普金斯大学临床试验中心协调。经过详细的基线特征分析后，参与者将被随机分配接受舍曲林或安慰剂治疗至少 12 周，并随访长达 24 周。所有患者和护理人员都将接受针对阿尔茨海默病和抑郁症的心理社会干预。患者结果将包括：抑郁障碍的整体改善、抑郁量表的评级、生活质量、认知功能、日常生活活动、行为障碍和不良事件。护理人员的结果将包括：抑郁、生活质量和护理负担。关于第一个研究目标，分析将比较两个治疗组在前十二周内的患者情绪结果。关于第二个研究目标，分析将比较两个治疗组 24 周内关键 AD 患者结局（认知、功能、生活质量、行为）和护理人员结局的轨迹。关于第三个目标，分析将使用三种不同的综合征定义来检查阿尔茨海默氏症背景下抑郁症状和抑郁综合征的纵向过程：dAD、DSM-IV 和凭经验得出的“阿尔茨海默氏症相关情感障碍”。使用症状量表或每种综合征来定义 AD 抑郁症的预测有效性将根据各种研究结果以及抗抑郁治疗的疗效进行纵向评估。