Depression in Alzheimer's Disease-II

阿尔茨海默病的抑郁症-II

• 批准号: 6856467
• 负责人: BARBARA K MARTIN
• 金额: $ 31.65万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-06-05 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6856467
• 关键词: Alzheimer' s disease; behavior disorders; behavioral /social science research tag; caregivers; clinical research; clinical trial phase III; cognition; cooperative study; depression; disease /disorder etiology; drug adverse effect; functional ability; health care service utilization; human subject; human therapy evaluation; longitudinal human study; mental disorder chemotherapy; mental disorder diagnosis; patient oriented research; psychological aspect of aging; psychotherapy; 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，对患者及其照顾者有严重的不良后果。关于阿尔茨海默病相关抑郁症的病程或治疗方法的研究很少。这部分是由于缺乏有效的操作标准来定义阿尔茨海默病中的抑郁症。最近，NIMH召集了一个专家共识小组来制定阿尔茨海默病（dAD）抑郁症的标准草案，并确定该领域的研究重点。这些标准旨在促进进一步研究阿尔茨海默病抑郁症的病程和治疗。这项多中心研究的第一个目的是在一项为期12周的随机、对照、双盲试验中确定dAD患者是否对使用舍曲林进行抗抑郁治疗有反应。第二个目的是确定早期治疗阿尔茨海默病抑郁症是否会影响关键的非情绪结果，如认知、生活质量、日常生活活动和照顾者变量，持续超过24周。第三个目的是通过评估其病程和对治疗的反应来验证AD综合征，并与其他AD抑郁症诊断概念进行比较，超过6个月。这些目标与NIMH专家共识小组所阐述的优先事项一致。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：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。这项研究将由约翰霍普金斯临床试验中心协调。在详细的基线特征后，参与者将随机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、抑郁量表评分、生活质量、认知功能、日常生活活动、行为障碍和不良事件。照顾者的结果将包括：抑郁、生活质量和照顾负担。关于第一个研究目标，分析将比较两个治疗组在前12周的患者情绪结果。关于第二个研究目标，分析将比较两个治疗组在24周内患者关键AD患者结局（认知，功能，生活质量，行为）和护理者结局的轨迹。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病程：dAD、DSM-IV和经验得出的“阿尔茨海默氏症相关情感障碍”。使用症状量表或这些症状中的每一种来定义AD中抑郁症的预测有效性将根据各种研究结果和抗抑郁药物治疗的疗效进行纵向评估。