Fish oil for depression in multiple sclerosis

描述(由申请人提供)：Lynne Shinto，ND寻求为以患者为导向的指导研究职业发展奖提供资金，以获得设计和实施科学严格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先导研究。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，评估补充鱼油治疗多发性硬化症(MS)患者轻中度抑郁症的安全性和有效性。抑郁症在MS中比在许多其他慢性病中更常见，50%-60%的MS患者受到抑郁症的影响。最近发表的两项双盲安慰剂对照试验研究报告称，补充二十碳五酸乙酯(EEPA)可显著降低服用稳定剂量抗抑郁药物的原发性抑郁症患者的抑郁程度。鉴于多发性硬化症抑郁症的高患病率和鱼油的低副作用，一项研究是必要的。60名患有轻度到中度抑郁的多发性硬化症患者将被随机分为安慰剂组或每天7.2克鱼油组。受试者将接受稳定剂量的多发性硬化症疾病修正药物和抗抑郁药物。纳入研究和对治疗的反应将由汉密尔顿抑郁评定量表(HDRS)和贝克抑郁量表(BDI)确定；安全性将通过不良事件报告和实验室评估来衡量；依从性将通过红细胞脂肪酸分析来衡量。这项研究还将评估对据报道与抑郁症和MS相关的炎性介质的治疗效果。这一发现可能对抑郁症与其他炎症性疾病之间的关系具有一定的意义。为了确保她的研究培训取得成功，神户博士组建了一个由高素质导师组成的团队。丹尼斯·布德特，医学博士，部门临时主席。OHSU俄勒冈州MS中心主任Neuroology将担任Shinto博士的主要导师，并将在MS研究方面提供专业知识和指导。共同导师包括：OHSU精神病学副主席、精神病学教授兼OHSU精神病学和药理学教授Alfred Lewis医学博士；波特兰退伍军人医学中心精神病学首席和临床主任Peter Hauser医学博士；OHSU公共卫生和预防医学教授、俄勒冈州人类调查项目主任Cynthia Morris博士；OHSU神经学教授、微生物学和免疫学教授Arthur Vandenbark博士。刘易和豪泽博士将提供抑郁症研究方面的专业知识。莫里斯博士是辛托博士公共卫生项目的顾问，他将提供研究设计和数据管理方面的指导。范登巴克博士将提供免疫学测量方面的专业知识。在5年的授权期结束时，Shinto博士将获得公共卫生硕士学位，并将在进行临床试验方面接受过广泛的培训。她将在神经学和情绪障碍方面拥有一套独特的临床和研究技能。

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.