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

阿尔茨海默病研究 2 中的抑郁症 (DIADS-2)

• 批准号: 6616542
• 负责人: LON S SCHNEIDER
• 金额: $ 12.15万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-06-10 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6616542
• 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）：在阿尔茨海默氏病（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了严重的不利影响。关于与AD相关的抑郁症的课程或治疗的研究很少。这部分是由于缺乏确定AD抑郁症的经过验证的操作标准。最近，NIMH召集了一个专家共识小组，以制定有关阿尔茨海默氏病抑郁症（DAD）的标准草案，并在该领域建立研究优先事项。这些标准旨在促进对AD中抑郁症的课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确定在为期12周的随机，受控的双盲试验中，使用药物舍曲林对抗抑郁药的治疗做出反应。第二个目的是确定在24周内，是否会影响认知，生活质量，日常生活和照料者变量等关键的非事实结果。第三个目的是通过评估六个月以上抑郁症的其他诊断概念化来验证父亲综合症的病程和对治疗的反应。这些目标与NIMH专家共识小组所阐明的优先级是一致的。 130名符合父亲标准的患者及其护理人员将在五个临床中心招募：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州医科大学。这项研究将由约翰·霍普金斯临床试验中心协调。详细的基线表征后，参与者将与舍曲林或安慰剂进行随机处理至少十二周，然后最多24周。所有患者和护理人员都将接受阿尔茨海默氏症和抑郁症的社会心理干预措施。患者结果将包括：全球抑郁症，抑郁量表上的评分，生活质量，认知功能，日常生活活动，行为干扰和不良事件的全球改善。护理人员的结果将包括：抑郁，生活质量和照顾负担。关于第一个研究的目的，分析将在最初的十二周内对两个治疗组的患者情绪结局进行比较。关于第二项研究的目的，分析将在24周内将两个治疗组与患者关键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进行比较。关于第三个目标，分析将在阿尔茨海默氏症的背景下使用三种不同的综合症定义来检查抑郁症状和抑郁综合症的纵向过程：dad，dsm-iv和“阿尔茨海默氏症相关的情感障碍”的经验上是经验上的。使用症状量表或这些综合症中的每一种定义AD抑郁症的预测有效性将被纵向评估，以针对各种研究结局，并反对对抗抑郁治疗的反应有效性。