@article{5e7655d2ed2b401c8474b35db4192cc4,
title = "Long-Chain Omega-3 Fatty Acid Supplements in Depressed Heart Failure Patients: Results of the OCEAN Trial",
abstract = "Objectives: The goal of this study was to test the effects of long-chain omega-3 fatty acid supplementation on omega-3 levels, depressive symptoms, and other psychosocial factors, as well as other chronic heart failure (CHF)-related functional measures. Background: Patients with CHF and depression had low blood omega-3 concentrations that were associated with an elevated risk of mortality. Methods: This study was a randomized, double-blind, placebo-controlled pilot clinical trial using a 400/200 eicosapentaenoic acid (EPA)/docosahexaenoic acid (DHA) fish oil at 2 g and an almost pure EPA at 2 g, compared with a matched placebo, daily for 12 weeks for patients with CHF and major depressive disorder. Statistical analyses included the intention-to-treat population and “completers” (defined as participants consuming ≥70% of the capsules and completing the final endpoint evaluation between 10 and 14 weeks). Results: A total of 108 patients with CHF and major depressive disorder and a score ≥18 on the Hamilton Depression Scale who were randomized at 1:1:1 to the 3 interventions at 3 enrolling centers from June 12, 2014, to May 19, 2016; 80 (74.1%) qualified as completers. Intention-to-treat analyses revealed that the levels of all omega-3 variables were significantly elevated in the omega-3 groups, whereas the placebo group showed little change; there were no between-group differences with overall depression measurements. Per-protocol exploratory analyses showed that scores on the social functioning measurement of the 36-item Short Form Health Survey improved notably in the 400/200 EPA/DHA (p = 0.040) and EPA (p = 0.10) groups compared with the placebo group. Spearman correlation analysis indicated that increased omega-3 indices were associated with improved cognitive depressive symptoms. Conclusions: Omega-3 supplementation resulted in significant increases in omega-3 levels in red blood cell counts, corresponding to a particular compound of omega-3. Changes in cognitive depressive symptoms and social function were in favor of the omega-3 supplementation. Further studies with larger sample sizes are necessary to confirm the benefits of omega-3 supplementation on modifying psychosocial factors for patients with CHF. (Omega-3 Supplementation for Co-Morbid Depression and Heart Failure Treatment [OCEAN]; NCT02057406)",
keywords = "congestive heart failure, long-chain omega-3 fatty acids, major depressive disorder",
author = "Wei Jiang and Whellan, {David J.} and Adams, {Kirkwood F.} and Babyak, {Michael A.} and Boyle, {Stephen H.} and Wilson, {Jennifer L.} and Patel, {Chetan B.} and Rogers, {Joseph G.} and Harris, {William S.} and O'Connor, {Christopher M.}",
note = "Funding Information: The OCEAN study was a multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical pilot trial. It was funded by the National Institute of Mental Health and conducted by a team of cardiologists and a psychiatrist at the Duke University Health System, Thomas Jefferson University, and the University of North Carolina at Chapel Hill; the trial was coordinated by the Duke Clinical Research Institute. We chose to use a centralized psychiatry oversight, provided by the study{\textquoteright}s principal investigator (W.J.), for this multicenter clinical trial. The centralized psychiatric oversight consisted of formal face-to-face training of study personnel on providing formal psychiatric diagnostic interviews, administering study instruments, and participants{\textquoteright} safety monitoring; weekly teleconferences for reviewing the enrollment and study process of each participant; and a 24-h on-call service for emergent issues from each participating site. The protocol was approved by the institutional review boards of all 3 institutes and the Duke Clinical Research Institute. Written informed consent was obtained from every participant. Funding Information: This study was supported by the National Institute of Mental Health collaborative R34 mechanism (NIMH 1R34MH097034). The sponsors of this study played no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or the preparation, review, and approval of the manuscript. Dr. Harris is the owner of OmegaQuant Analytics, LLC, which performed the omega-3 assays for this study free of charge. Dr. O{\textquoteright}Connor has received funding from Actelion Pharmaceuticals Ltd., Amgen Inc., Biscardia LLC, Faculty Connection, GE Healthcare, Ikaria, Novella Clinical Inc., Pfizer Inc., Pozen, and Roche Diagnostics; serves as a consultant for Novartis, HeartWare, ResMed, Johnson & Johnson, Gilead, Critical Diagnostics, BG Medicine, Otsuka, Astellas, Cytokinetics, and Capricor; and holds stock or stock options in Neurotronik/Interventional Autonomics Corporation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Barry Greenberg, MD, served as Guest Editor for this paper. Publisher Copyright: {\textcopyright} 2018 American College of Cardiology Foundation Copyright: Copyright 2019 Elsevier B.V., All rights reserved.",
year = "2018",
month = oct,
doi = "10.1016/j.jchf.2018.03.011",
language = "English (US)",
volume = "6",
pages = "833--843",
journal = "JACC: Heart Failure",
issn = "2213-1779",
publisher = "Elsevier BV",
number = "10",
}