Omega-3 for Depression and Other Cardiac Risk Factors

描述（由申请人提供）：抑郁症是急性心肌梗死（MI）和不稳定型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vs安慰剂，舍曲林加认知治疗vs常规治疗）报告急性心肌梗死或不稳定型心绞痛后抑郁症状只有适度减少，而且许多接受治疗的患者仍然抑郁。两项研究均未报告接受治疗的患者有更好的医疗结果。早期的研究发现，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，需要更有效的治疗方法来消除急性心肌梗死或不稳定型心绞痛患者的抑郁和改善医疗结果。Omega-3脂肪酸（FAs）已被证明可以增强抗抑郁药对重度抑郁症的疗效，并改善几种心脏风险因素。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脂肪酸是否能同时改善心肌梗死后患者的抑郁和降低心血管危险因素。本研究将测试一种治疗冠心病共病抑郁症的新方法。170名符合DSM-IV当前重度抑郁发作标准，并且在急性心肌梗死或不稳定型心绞痛3-4个月后汉密尔顿抑郁量表得分19分或更高的患者将被纳入一项随机、双盲、安慰剂对照的-3增强舍曲林试验。参与者将被随机分配接受10周的舍曲林加omega-3或舍曲林加安慰剂。在基线和10周后，受试者将完成1)抑郁和心理社会功能评估；2) 24小时心电图监测心率变异性分析；3)抽血测量促凝剂和促炎标志物以及血浆中舍曲林和omega-3的水平。如果这项研究表明omega-3可以减少抑郁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型心绞痛住院后的生存率。

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.