Fish oil for depression in multiple sclerosis

鱼油治疗多发性硬化症抑郁症

• 批准号: 6909997
• 负责人: LYNNE H SHINTO
• 金额: $ 10.77万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6909997
• 关键词: alternative medicine; antidepressants; blood chemistry; clinical research; cytokine; depression; diet therapy; dietary supplements; human subject; human therapy evaluation; liver function; marine animal oil; metabolism; multiple sclerosis; neuropsychological tests; nutrition related tag; omega 3 fatty acid; patient oriented research; therapy adverse effect

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，ND寻求资助指导以患者为导向的研究职业发展奖，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MPH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点研究，评估鱼油补充剂对多发性硬化症（MS）患者轻中度抑郁症的安全性和有效性。抑郁症在MS中比许多其他慢性疾病更常见，50-60%的MS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，补充乙基二十碳五烯酸（EEPA）显着减少抑郁症的原发性抑郁症患者的稳定剂量的抗抑郁药。鉴于MS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例轻度至中度抑郁的MS受试者将随机接受安慰剂或7.2 g/天鱼油。受试者将接受稳定剂量的MS疾病缓解药物和抗抑郁药物治疗。将通过汉密尔顿抑郁评定量表（HDRS）和贝克抑郁量表（BDI）确定研究入选和治疗应答;将通过不良事件报告和实验室评估测量安全性;将通过红细胞脂肪酸分析测量依从性。这项研究还将评估对炎症介质的治疗效果，据报道，这些炎症介质与抑郁症和MS相关。这一发现可能对抑郁症与其他炎症性疾病之间的关系有意义。为了确保她的研究培训的成功，Shinto博士组建了一个高素质的导师团队。Dennis Boudette，医学博士，部门临时主席。OHSU俄勒冈州MS中心主任，神经病学博士将担任Shinto博士的主要导师，并将提供MS研究方面的专业知识和指导。共同导师包括：Alfred Lewy，医学博士，博士，精神病学副主席，精神病学教授，OHSU药理学; Peter豪瑟，医学博士，波特兰VA医疗中心精神病学和临床主任主任; Cynthia Morris，博士，公共卫生和预防医学教授，OHSU俄勒冈州人类研究项目主任;亚瑟范登巴克博士，OHSU神经学、微生物学和免疫学教授。Lewy和豪瑟博士将提供抑郁症研究方面的专业知识。Morris博士是Shinto博士的MPH项目顾问，将提供研究设计和数据管理方面的指导。Vandenbark博士将提供免疫测量方面的专业知识。在5年的资助期结束时，Shinto博士将获得公共卫生硕士学位，并将在临床试验方面接受广泛的培训。她将拥有一套独特的临床和研究技能，在神经和情绪障碍。