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Fish oil for depression in multiple sclerosis

鱼油治疗多发性硬化症抑郁症

基本信息

批准号：
7459746
负责人：
LYNNE H SHINTO
金额：
$ 11.77万
依托单位：
OREGON HEALTH & SCIENCE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-07-01 至 2010-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7459746
关键词：
Acute Adverse effects Adverse event Affect Anti-Inflammatory Agents Anti-inflammatory Antidepressive Agents Beck depression inventory Blinded Blood Platelets Chairperson Chronic Chronic Disease Clinical Clinical Research Clinical Trials Conduct Clinical Trials Diagnosis Disease Disease remission Doctor of Philosophy Dose Double-Blind Method Effectiveness Ensure Erythrocytes Fatigue Fatty Acids Fish Oils Funding Goals Grant Hamilton Rating Scale for Depression High Prevalence Human Immunologics Immunology Inflammatory Interferon Type II Interleukin-10 Interleukin-2/Interleukin-6 Interleukin-4 Interleukin-6 Laboratories Long-Term Effects Major Depressive Disorder Measurement Measures Mediator of activation protein Medical center Mental Depression Mentored Patient-Oriented Research Career Development Award Mentors Metabolic Microbiology Mitogens Monitor Mood Disorders Multiple Sclerosis Neurologic Neurology Omega-3 Fatty Acids Oregon Patients Peripheral Peripheral Blood Mononuclear Cell Pharmaceutical Preparations Pharmacology Phase Pilot Projects Placebo Control Placebos Preventive Medicine Process Psychiatry Public Health Publishing Qualifying Randomized Red Blood Cell Count Reporting Research Research Design Research Personnel Research Training Safety Score Supplementation Symptoms Time Training Tumor Necrosis Factor-alpha career clinical effect cytokine data management day design disability eicosapentanoic acid improved liver function pill professor programs response skills success treatment effect

项目摘要

DESCRIPTION (provided by applicant): Lynne Shinto, ND seeks funding for a Mentored Patient-Oriented Research Career Development Award to obtain the skills necessary to design and implement scientifically rigorous clinical trials. Her career goal is to become an independent clinical researcher. The plan for achieving these objectives include obtaining an MPH and implementation of a clinical pilot study. Dr. Shinto will conduct a 6-month double-blind placebo controlled pilot study evaluating the safety and effectiveness of fish oil supplementation for mild-moderate depression in people with multiple sclerosis (MS). Depression is more common in MS than in many other chronic illnesses with 50-60% of MS patients affected by depression. Two recently published double blind placebo controlled pilot studies have reported that supplementation with ethyl eicosapentanoic acid (EEPA) significantly reduced depression in subjects with primary depression on stable doses of antidepressants. A study is warranted given the high prevalence of depression in MS and fish oil's low side effect profile. Sixty MS subjects with mild to moderate depression will be randomized to placebo or 7.2 g/day fish oil. The subjects will be on stable doses of MS disease-modifying medication and of antidepressants. Study inclusion and response to treatment will be determined by the Hamilton Depression Rating Scale (HDRS) and Beck Depression Inventory (BDI); safety will be measured by adverse events reports and laboratory assessment; compliance will be measured by red blood cell fatty acid analysis. This study will also evaluate the treatment effect on inflammatory mediators reported to be associated with both depression and MS. This finding may have implication for the relationship between depression in other inflammatory diseases. To ensure the success of her research training, Dr. Shinto has assembled a team of highly qualified mentors. Dennis Boudette, MD, Interim chairman, Dept. of Neurology, Director of the Oregon MS Center at OHSU, will serve as Dr. Shinto's primary mentor and will provide expertise and guidance in MS research. Co-mentors include: Alfred Lewy, MD, PhD, Vice Chairman of Psychiatry, and Professor of Psychiatry, and Pharmacology at OHSU; Peter Hauser, MD, Chief of Psychiatry & Clinical Director at the Portland VA Medical Center; Cynthia Morris, PhD, MPH, Professor of Public Health & Preventative Medicine, and Director of the Oregon Human Investigators Program at OHSU; Arthur Vandenbark, PhD, Professor of Neurology, and Microbiology & Immunology at OHSU. Drs. Lewy and Hauser will provide expertise in depression research. Dr. Morris, Dr. Shinto's advisor for the MPH program, will provide guidance on study design and data management. Dr. Vandenbark will provide expertise on immunologic measurements. At the end of the 5-year grant period Dr. Shinto will have obtained an MPH and will have had extensive training in the conduct of clinical trials. She will possess a unique set of clinical and research skills in both neurologic and mood disorders.

描述（由申请人提供）：Lynne Shinto博士为指导患者导向的研究职业发展奖寻求资金，以获得设计和实施科学严谨的临床试验所需的技能。她的职业目标是成为一名独立的临床研究人员。实现这些目标的计划包括获得公共卫生硕士学位和实施临床试点研究。Shinto博士将进行一项为期6个月的双盲安慰剂对照试验，评估鱼油补充剂对多发性硬化症（MS）患者轻度至中度抑郁症的安全性和有效性。抑郁症在多发性硬化症中比在许多其他慢性疾病中更常见，50-60%的多发性硬化症患者受抑郁症影响。最近发表的两项双盲安慰剂对照试点研究报告称，补充乙基二十碳五烯酸（EEPA）可显著减轻服用稳定剂量抗抑郁药的原发性抑郁症患者的抑郁症状。鉴于多发性硬化症中抑郁症的高患病率和鱼油的低副作用，有必要进行研究。60名患有轻度至中度抑郁症的多发性硬化症患者将被随机分配到安慰剂组或每天7.2 g鱼油组。受试者将服用稳定剂量的MS疾病缓解药物和抗抑郁药。研究纳入和治疗反应将通过汉密尔顿抑郁评定量表（HDRS）和贝克抑郁量表（BDI）来确定；安全性将通过不良事件报告和实验室评估来衡量；通过红细胞脂肪酸分析来测量依从性。本研究还将评估与抑郁症和多发性硬化症相关的炎症介质的治疗效果。这一发现可能对抑郁症与其他炎症性疾病之间的关系有所启示。为了确保她的研究培训取得成功，Shinto博士组建了一个高素质的导师团队。Dennis Boudette医学博士，神经内科临时主席，OHSU俄勒冈多发性硬化症中心主任，将担任Shinto博士的主要导师，并将在多发性硬化症研究方面提供专业知识和指导。共同导师包括：Alfred Lewy，医学博士，精神病学副主席，OHSU精神病学和药理学教授；Peter Hauser医学博士，波特兰退伍军人医疗中心精神病学主任和临床主任；辛西娅·莫里斯博士，公共卫生和预防医学教授，OHSU俄勒冈州人类调查员项目主任；Arthur Vandenbark博士，OHSU神经学、微生物学和免疫学教授。Drs。路易和豪瑟将提供抑郁症研究方面的专业知识。Shinto博士的公共卫生硕士项目顾问Morris博士将为研究设计和数据管理提供指导。范登巴克博士将提供免疫学测量方面的专业知识。在5年资助期结束时，Shinto博士将获得公共卫生硕士学位，并将接受临床试验方面的广泛培训。她将在神经和情绪障碍方面拥有独特的临床和研究技能。