Depression in Alzheimer's Disease-II

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严重的公共卫生问题，对患者及其护理人员造成严重不良后果。很少有研究与AD相关的抑郁症的过程或治疗。这部分是由于缺乏有效的操作标准来定义AD中的抑郁症。最近，NIMH召集了一个专家共识小组，以制定阿尔茨海默病（dAD）抑郁症的标准草案，并确定该领域的研究重点。这些标准的目的是为了促进进一步研究的过程和治疗抑郁症的AD。拟议的多中心研究的第一个目的是确定dAD患者是否对使用药物舍曲林的抗抑郁治疗有反应，这是一项为期12周的随机、对照、双盲试验。第二个目的是确定早期治疗AD抑郁症是否会影响24周内的关键非情绪结果，如认知，生活质量，日常生活活动和护理人员变量。第三个目的是通过评估其病程和对治疗的反应来验证dAD综合征，并与AD中抑郁症的其他诊断概念进行比较，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的研究中：约翰·霍普金斯大学、南加州大学、罗切斯特大学、宾夕法尼亚大学和医科大学。南卡罗来纳州。该研究将由约翰霍普金斯临床试验中心协调。在详细的基线表征之后，参与者将被随机分配至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阿尔茨海默病和抑郁症的心理社会干预。患者结局将包括：抑郁障碍的总体改善、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。关于第一个研究目的，分析将比较两个治疗组在前12周内的患者情绪结果。关于第二个研究目的，分析将比较两个治疗组24周内患者危重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，分析将检查纵向过程中的抑郁症状和抑郁综合征的背景下，阿尔茨海默氏症使用三种不同的综合征的定义：dAD，DSM-IV，和“阿尔茨海默氏症相关的情感障碍”的经验。使用症状量表或这些综合征中的每一种来定义AD中的抑郁的预测有效性将根据各种研究结果以及抗抑郁药治疗的疗效进行纵向评估。

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.