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

3/3-多部位 - Omega-3 治疗抑郁症共病

• 批准号: 8510046
• 负责人: KIRKWOOD F ADAMS
• 金额: $ 24.4万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 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/8510046
• 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）：本阶段IIA概念验证试验将试图回答以下问题：“在慢性心力衰竭（HF）和重度抑郁症（MDD）的成年患者中，欧米茄3是否补充到通常的护理中，可以通过改善血液omega 3浓度来改善中度至严重的MDD。我们的长期目标是扩大知识，以改善HF患者HF患者的HF结果，生活质量和预后，并减轻这些疾病所带来的经济负担。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很大。尽管市场上只有SSRI（在市场上广泛的抗抑郁药中）被认为是心脏病患者的安全类型，但在减少最近完善的，精心设计的sadhart-CHF试验中，塞特塔林在减少抑郁症或心脏结果方面未能表现出优于安慰剂，由469 HF患者组成。 SADHART-CHF生物标志物的替代表明，Omega 3很低，与SADHART-CHF参与者的死亡率增加有关。这项生物标志物研究表明，在低欧米茄3的背景下，SSRI可能对HF患者有害。 Omega 3补充剂可改善HF患者的CV预后，但是抑郁症患者是否改善抑郁症是未知的。根据彻底的文献综述和专家的看法，我们选择在安慰剂对照试验中进行调查，两种Omega 3补充剂的抗抑郁作用，400/200 EPA/DHA FISHIL FISH OIL X4和几乎纯EPA 2G，每天服用HF和中度至中等范围的患者，每天服用每天的EPA 2G（12周）。我们将在补充12周之前和之后评估Omega 3浓度，以评估Omega 3中的变化与治疗反应如何相关。这项多站点初步研究的结果将提供数据，以允许在随后的RCT中进行准确的样品计算，并为选择在随后的临床试验中使用精神病和生物学成果的指导，以及测量Omega 3浓度的临床价值，以指导欧米茄3补充欧米茄3补充个性化护理。 。