Safety and Efficacy of Sertraline for Depression CHF

舍曲林治疗抑郁症 CHF 的安全性和有效性

• 批准号: 6576978
• 负责人: RANGA R KRISHNAN
• 金额: $ 109.73万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-02-20 至 2008-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6576978
• 关键词: behavioral /social science research tag; clinical research; clinical trials; comorbidity; congestive heart failure; depression; drug screening /evaluation; human morbidity; human mortality; human subject; interview; longitudinal human study; myocardial ischemia /hypoxia; outcomes research; patient oriented research; quality of life; sertraline

DESCRIPTION (provided by applicant): The significance of co-morbid depression upon the medically ill has recently been recognized in the medical literature. Higher prevalence rates of mood disorders above that of the normal population has been found in patients who suffer from chronic medical illnesses, including vascular disease (cerebrovascular and coronary artery disease). Additional work has shown increased in-patient hospitalizations, cost of care, morbidity and mortality in these patients. More than 2 million United States citizens suffer from congestive heart failure (CHF), accounting for the highest category for hospitalization in the Medicare population, with annual expenses exceeding $10 billion. One leading source of heart failure is ischemic heart disease. Despite knowledge that depressive disorders lead to increased morbidity, mortality and poorer outcomes in ischemic heart disease, little is currently known about the association of CHF and depression. There is evidence that the rate of depression may be high in the CHF population, but no studies have addressed the impact on morbidity and mortality in CHF patients when depression is adequately treated. Funding is requested for a two site, prospective placebo treatment of patients with congestive heart failure and clinically diagnosed major depression. Patients will be enrolled in this study with clinically diagnosed heart failure of NYHA functional > II. Patients will be interviewed and evaluated for major depression by use of the protocol developed by the NIMH-supported Duke Center for the Study of Depression in the Elderly. This includes sections that assess depressive symptoms, psychiatric co-morbidity, cognitive status, functional status and disability, daily and chronic stress, and social support, the longitudinal component of this study will include collecting data on all enrolled subjects. Information collected in these follow-up contacts will include deaths, re-hospitalizations, cardiac events, functional status/quality of life measures, and level of depressive symptoms.

描述（由申请人提供）：最近在医学文献中认识到了共病抑郁症对医学疾病的重要性。在患有慢性疾病，包括血管疾病（脑血管和冠状动脉疾病）的患者中，情绪障碍的发病率高于正常人群。进一步的工作表明，这些患者的住院率、护理费用、发病率和死亡率都有所增加。超过200万美国公民患有充血性心力衰竭（CHF），是医疗保险人群中住院治疗的最高类别，每年的费用超过100亿美元。心力衰竭的一个主要来源是缺血性心脏病。尽管了解抑郁症导致缺血性心脏病发病率、死亡率和预后不良增加，但目前对CHF和抑郁症的相关性知之甚少。有证据表明，CHF人群中抑郁症的发病率可能很高，但尚无研究探讨抑郁症得到充分治疗时对CHF患者发病率和死亡率的影响。要求为充血性心力衰竭和临床诊断为重度抑郁症的患者提供两个地点的前瞻性安慰剂治疗资金。患者将入选本研究，临床诊断为NYHA功能> II的心力衰竭。患者将接受访谈，并使用由NIMH支持的杜克老年抑郁症研究中心制定的方案评估重度抑郁症。这包括评估抑郁症状、精神病合并症、认知状态、功能状态和残疾、日常和慢性压力以及社会支持的部分，本研究的纵向部分将包括收集所有入组受试者的数据。在这些随访联系中收集的信息将包括死亡、再次住院、心脏事件、功能状态/生活质量指标和抑郁症状水平。