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.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23AT002155-03
Application #
7088799
Study Section
Special Emphasis Panel (ZAT1-CP (12))
Program Officer
Stoney, Catherine
Project Start
2004-07-01
Project End
2009-06-30
Budget Start
2006-07-01
Budget End
2007-06-30
Support Year
3
Fiscal Year
2006
Total Cost
$110,972
Indirect Cost
Name
Oregon Health and Science University
Department
Neurology
Type
Schools of Medicine
DUNS #
096997515
City
Portland
State
OR
Country
United States
Zip Code
97239
Shinto, Lynne; Marracci, Gail; Mohr, David C et al. (2016) Omega-3 Fatty Acids for Depression in Multiple Sclerosis: A Randomized Pilot Study. PLoS One 11:e0147195