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

1/3-多位点 - Omega-3 治疗抑郁症共病

• 批准号: 8706234
• 负责人: WEI JIANG
• 金额: $ 23.55万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8706234
• 关键词: Academic Medical Centers; Adult; African American; Antidepressive Agents; Asians; Behavior Therapy; Biological; Biological Markers; Blood; Blood specimen; Cardiac; Cardiovascular Diseases; Cardiovascular system; Caring; Cessation of life; Chronic; Clinical; Clinical Research; Clinical Trials; Collaborations; Communication; Data; Data Collection; Depressed mood; Docosahexaenoic Acids; Economic Burden; Endogenous depression; Enrollment; Ensure; Event; Expert Opinion; Fish Oils; Future; Goals; Health; Healthcare; Heart Diseases; Heart failure; Hospitalization; Intervention Trial; Knowledge; Latino; Major Depressive Disorder; Marketing; Measures; Medical; Medicine; Mental Depression; Mental Health; Modeling; Monitor; Morbidity - disease rate; North Carolina; Nutritionist; Omega-3 Fatty Acids; Outcome; Participant; Patients; Phase; Pilot Projects; Placebos; Population; Preparation; Probability; Protocols documentation; Psychiatric Diagnosis; Psychiatrist; Psychosocial Factor; Public Health; Qualifying; Quality of life; Recording of previous events; Recruitment Activity; Regulation; Research; Research Infrastructure; Research Institute; Resources; Review Literature; Risk; Safety; Sampling; Schedule; Selective Serotonin Reuptake Inhibitor; Sertraline; Services; Site; Supplementation; Teleconferences; Testing; Therapeutic Effect; Training; United States National Institutes of Health; Universities; Woman; Work; base; burden of illness; capsule; cardiology service; cost; depressive symptoms; design; effective intervention; experience; improved; meetings; mortality; outcome forecast; peripheral blood; pilot trial; placebo controlled study; protective effect; public health relevance; success; treatment as usual; treatment response

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. .

描述（由申请人提供）：该IIa期概念验证试验将尝试回答以下问题：“在患有慢性心力衰竭（HF）和重度抑郁症（MDD）的成人患者中，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MDD心力衰竭患者的心力衰竭结局、生活质量和预后，并减少这些疾病造成的经济负担。抑郁症是一个严重的公共卫生问题，导致心脏病患者的发病率和死亡率显着。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安全的抗抑郁药，但在最近完成的、设计良好并进行的SADHART-CHF试验中，舍曲林未能显示出在减少抑郁或心脏结局方面优于安慰剂，该试验包括469例MDD HF患者。SADHART-CHF生物标志物子研究表明，Omega 3含量较低，与SADHART-CHF参与者的死亡率增加相关。这项生物标志物研究表明，在低欧米伽3的背景下，SSRI可能对HF患者有害。Omega 3补充剂改善HF患者的CV预后，但它是否改善抑郁HF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补充剂的抗抑郁作用，400/200 EPA/DHA鱼油胶囊X4和几乎纯EPA 2g，每天（12周）服用HF和中度至重度MDD患者。我们将在补充12周之前和之后评估omega 3浓度，以评估omega 3的变化如何与治疗反应相关。这项多中心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，并指导在随后的临床试验中选择精神和生物学结局，以及测量omega 3浓度的临床价值，以指导omega 3补充剂用于个性化护理。.