Safety and Efficacy of Sertraline for Depression CHF

描述（由申请人提供）：最近在医学文献中已经认识到共病性抑郁症对医学疾病的重要性。在患有慢性医学疾病，包括血管疾病（脑血管和冠状动脉疾病）的患者中，情绪障碍的患病率高于正常人群。进一步的工作表明，这些病人的住院率、护理费用、发病率和死亡率都有所增加。200多万美国公民患有充血性心力衰竭（CHF），这是医疗保险人口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原因是缺血性心脏病。尽管已知抑郁症会导致缺血性心脏病的发病率、死亡率增加和预后较差，但目前对CHF和抑郁症的关联知之甚少。有证据表明，CHF人群中抑郁症的发病率可能很高，但没有研究表明抑郁症得到充分治疗对CHF患者发病率和死亡率的影响。申请资金用于充血性心力衰竭和临床诊断为重度抑郁症的患者的两个地点，前瞻性安慰剂治疗。临床诊断为NYHA功能性> II型心力衰竭的患者将被纳入本研究。患者将接受访谈，并根据nimh支持的杜克老年抑郁症研究中心制定的方案对重度抑郁症进行评估。这包括评估抑郁症状、精神合并症、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登记受试者的数据。在这些随访接触中收集的信息将包括死亡、再次住院、心脏事件、功能状态/生活质量测量和抑郁症状水平。

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.