1/3-Multi-Site - Omega-3 for Co-Morbid Depression & HF Treatment (OCEAN)

描述（由申请人提供）：这项IIa期概念验证试验将试图回答以下问题：“在患有慢性心力衰竭（HF）和重度抑郁症（MDD）的成年患者中，在常规护理中添加omega - 3补充剂是否通过改善血液omega - 3浓度来改善中度至重度MDD”。我们的长期目标是拓宽知识，以改善心力衰竭合并重度抑郁症患者的预后、生活质量和预后，并减轻这些疾病带来的经济负担。抑郁症是一个严重的公共卫生问题，是心脏病患者发病率和死亡率的重要原因。虽然在市场上广泛的抗抑郁药中，只有SSRIs被认为是心脏病患者的安全抗抑郁药，但在最近完成的、设计良好并进行的SADHART-CHF试验中，舍曲林在减少抑郁或心脏结局方面未能显示出优于安慰剂的优势，该试验由469名合并重度抑郁症的心衰患者组成。SADHART-CHF生物标志物亚研究表明，在SADHART-CHF参与者中，Omega - 3水平低且与死亡率增加有关。这项生物标志物研究表明，在低omega - 3的情况下，SSRI可能对HF患者有害。Omega - 3补充剂可改善心衰患者的CV预后，但是否能改善心衰患者的抑郁尚不清楚。基于全面的文献综述和专家的意见，我们选择在安慰剂对照试验中研究两种omega - 3补充剂，400/200 EPA/DHA鱼油胶囊X4和几乎纯EPA 2g，每天服用（12周）对HF和中重度重度重度抑郁症患者的抗抑郁效果。我们将评估补充12周前后的omega - 3浓度，以评估omega - 3的变化与治疗反应的关系。这项多地点试点研究的结果将提供数据，以便在随后的随机对照试验中进行准确的样本计算，并指导后续临床试验中使用的精神病学和生物学结果的选择，以及测量omega - 3浓度以指导个体化护理中omega - 3补充的临床价值。

DESCRIPTION (provided by applicant): This Phase IIa Proof of Concept trial will attempt to answer the following question: "In adult patients with chronic heart failure (HF) and major depressive disorder (MDD), does omega 3 supplementation added to usual care improve moderate-to-severe MDD via improving blood omega 3 concentrations". Our long-term goal is to broaden the knowledge to improve HF outcomes, quality of life and prognosis of HF patients with MDD, and to reduce the economic burden resulting from these conditions. Depression is a serious public health concern that contributes to significant morbidity and mortality in patients with cardiac diseases. While only SSRIs, among a broad range of antidepressants on the market, are considered a safe type of antidepressant for patients with cardiac diseases, sertraline failed to show superiority over placebo in reducing depression or cardiac outcomes in the recently completed, well designed and conducted SADHART-CHF trial consisting of among 469 HF patients with MDD. The SADHART-CHF biomarker substudy demonstrated that Omega 3 is low and associated with increased mortality in the SADHART-CHF participants. This biomarker study indicates that within the context of low omega 3, SSRI may be detrimental for HF patients. Omega 3 supplements improve CV prognosis in HF patients but whether it improves depression for the depressed HF patients is unknown. Based on a thorough literature review and the opinion of experts, we chose to investigate in a placebo controlled trial, the antidepressant effects of two omega 3 supplements, 400/200 EPA/DHA Fish Oil capsule X4 and almost pure EPA 2g, taken daily (12-weeks) for patients with HF and moderate-to-severe MDD. We will assess the omega 3 concentration prior to and after 12 weeks of supplementation in order to assess how changes in omega 3 relate to treatment responses. The results of this multi-site pilot study will provide data to allow an accurate sample calculation in a subsequent RCT and guidance on selection of psychiatric and biological outcomes for use in a subsequent clinical trial and the clinical value of measuring omega 3 concentrations to guide omega 3 supplementation for individualized care. .