Omega-3 for Depression and Other Cardiac Risk Factors

描述（由申请人提供）：抑郁是急性心肌梗死（MI）和不稳定型心绞痛后发病率和死亡率的危险因素。最近的2项临床试验（舍他林与安慰剂，舍曲林加认知治疗与常规治疗）报告，急性MI或不稳定型心绞痛后抑郁症仅适度减少，许多接受治疗的患者仍然抑郁。两项研究都没有报告治疗患者的医疗结果更好。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，需要更有效的治疗来消除抑郁症并改善急性MI或不稳定型心绞痛患者的医疗结果。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，并改善几个心脏病风险因素。然而，这些发现是在不同的研究领域发展起来的。以前没有研究调查omega-3脂肪酸是否可以同时改善MI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新的方法来治疗冠心病合并抑郁症。170例符合DSM-IV标准的重度抑郁发作患者，在急性心肌梗死或不稳定型心绞痛后3-4个月，汉密尔顿抑郁量表评分≥ 19分，将入选一项随机、双盲、安慰剂对照的舍曲林omega-3增强试验。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10周。在基线和10周后再次，受试者将完成1）抑郁和心理社会功能的评估; 2）用于心率变异性分析的24小时ECG监测;和3）抽血以测量促凝血和促炎标志物以及舍曲林和ω-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，我们将有基础提出一项更大的临床试验，以确定它是否也可以改善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.