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）：抑郁症是急性心肌梗塞（MI）和不稳定心绞痛后发病​​和死亡的危险因素。最近的 2 项临床试验（舍曲林与安慰剂、舍曲林加认知治疗与常规治疗）报告显示，急性心肌梗死或不稳定心绞痛后的抑郁程度仅略有减轻，而且许多接受治疗的患者仍然处于抑郁状态。两项研究均未报告接受治疗的患者有更好的医疗结果。早期研究发现，即使是亚临床抑郁症也会增加心脏病患者的死亡风险。因此，需要更有效的治疗来消除急性心肌梗死或不稳定心绞痛患者的抑郁症并改善其医疗结果。 Omega-3 脂肪酸 (FA) 已被证明可以增强抗抑郁药治疗重度抑郁症的功效，并改善多种心脏危险因素。然而，这些发现是在不同的研究领域中发展起来的。之前没有研究调查 omega-3 FA 是否可以同时改善心梗后患者的抑郁症并减少心血管危险因素。这项研究将测试一种治疗先心病合并症重度抑郁症的新方法。 170 名符合当前重度抑郁发作 DSM-IV 标准且在急性心肌梗死或不稳定心绞痛 3-4 个月后汉密尔顿抑郁量表得分为 19 或更高的患者将被纳入一项随机、双盲、舍曲林 omega-3 增强的安慰剂对照试验。参与者将被随机分配接受舍曲林加 omega-3 或舍曲林加安慰剂治疗，为期 10 周。在基线和 10 周后，受试者将完成 1) 抑郁症和心理社会功能评估； 2）24小时心电监测，进行心率变异性分析； 3) 抽血测量促凝血和促炎标记物以及舍曲林和 omega-3 的血浆水平。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，我们将有基础提出更大规模的临床试验，以确定它是否也可以提高急性心肌梗死或不稳定心绞痛住院后的生存率。