Omega-3 for Depression and Other Cardiac Risk Factors

Omega-3 治疗抑郁症和其他心脏危险因素

• 批准号: 7012819
• 负责人: ROBERT M CARNEY
• 金额: $ 73.06万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-02-01 至 2009-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7012819
• 关键词: angina pectoris; biomarker; blood chemistry; cardiovascular disorder prevention; cardiovascular disorder risk; chemoprevention; clinical research; clinical trials; comorbidity; dietary supplements; electrocardiography; human subject; human therapy evaluation; major depression; mental disorder chemotherapy; myocardial infarction; nutrient drug interaction; nutrition related tag; omega 3 fatty acid; patient oriented research; sertraline

DESCRIPTION (provided by applicant): Depression is a risk factor for morbidity and mortality after acute myocardial infarction (MI) and unstable angina. 2 recent clinical trials (sertaline vs. placebo, sertraline plus cognitive therapy vs. usual care) reported only modest reductions in depression following an acute MI or unstable angina, and many treated patients remained depressed. Neither study reported better medical outcomes in the treated patients. Earlier studies found that even subclinical depression increases the risk of mortality in cardiac patients. Thus, more effective treatments are needed to eliminate depression and improve medical outcomes in patients following an acute MI or unstable angina. Omega-3 fatty acids (FAs) have been shown to augment the efficacy of antidepressants for major depression and to improve several cardiac risk factors. However, these findings have evolved in separate lines of research. No previous study has investigated whether omega-3 FAs can simultaneously improve depression and reduce cardiovascular risk factors in post-MI patients. This study will test a novel approach to the treatment of comorbid major depression in CHD. 170 patients who meet the DSM-IV criteria for a current major depressive episode and who score 19 or higher on the Hamilton Rating Scale for Depression 3-4 months after an acute MI or unstable angina will be enrolled in a randomized, double-blind, placebo-controlled trial of omega-3 augmentation of sertraline. The participants will be randomly assigned to receive sertraline plus omega-3 or sertraline plus placebo for 10 weeks. At baseline and again after 10 weeks, the subjects will complete 1) assessments of depression and psychosocial functioning; 2) 24 hour ECG monitoring for heart rate variability analysis; and 3) blood draws to measure procoagulant and proinflammatory markers and plasma levels of sertraline and omega-3. If this study shows that omega-3 reduces depression and improves cardiovascular disease markers, we will have a basis for proposing a larger clinical trial to determine whether it can also improve survival after hospitalization for acute MI or unstable angina.

描述（由申请人提供）：抑郁是急性心肌梗塞（MI）和不稳定心绞痛后发病​​率和死亡率的危险因素。 2最近的临床试验（Sertaline vs.安慰剂，Sertraline Plus认知疗法与通常的护理）报告仅报告了急性MI或不稳定心绞痛后抑郁症的适度减少，许多治疗的患者仍然抑郁。两项研究都报告了治疗患者的医疗结果更好。较早的研究发现，即使亚临床抑郁症也会增加心脏患者死亡率的风险。因此，需要更有效的治疗方法来消除急性MI或不稳定心绞痛后患者的抑郁症和改善医疗结果。欧米茄-3脂肪酸（FAS）已显示可增强抗抑郁药对重度抑郁症的疗效，并改善多种心脏危险因素。但是，这些发现已经在单独的研究领域演变。先前没有研究调查了Omega-3 FAS是否可以同时改善抑郁症并减少MI后患者的心血管危险因素。这项研究将测试一种新型方法，用于治疗CHD合并症重度抑郁症。符合当前重大抑郁发作的DSM-IV标准的170名患者，在急性MI或不稳定的心绞痛后3-4个月在汉密尔顿评分量表上得分19或更高，将参加一项随机，双盲，安慰剂控制的Omega-3增强官员的言语。参与者将被随机分配接受舍曲林加入欧米茄3或舍曲林加安慰剂10周。在基线和10周后，受试者将完成1）评估抑郁和社会心理功能； 2）24小时心电图监测心率可变性分析； 3）血液抽血以测量舍曲林和欧米茄-3的促凝剂和促炎标记以及血浆水平。如果这项研究表明，omega-3可以减少抑郁症并改善心血管疾病标志物，我们将有一个基础提出较大的临床试验，以确定急性MI或不稳定心绞痛后是否也可以提高住院后的生存率。