Double-Blind, Randomized, Placebo-Controlled Trials of Ethyl-Eicosapentanoate in the Treatment of Bipolar Depression and Rapid Cycling Bipolar Disorder
Abstract
Background The results of pilot trials suggest that omega-3 fatty acids may have efficacy in the treatment of mood symptoms in bipolar disorder.Methods We conducted a 4-month, randomized, placebo-controlled, adjunctive trial of ethyl-eicosapentanoate (EPA) 6 g/day in the treatment of bipolar depression and rapid cycling bipolar disorder. Subjects were receiving mood-stabilizing medications at therapeutic doses or plasma concentrations. The measures of efficacy were early study discontinuation, changes from baseline in depressive symptoms (Inventory for Depressive Symptomology total score) and in manic symptoms (Young Mania Rating Scale total score), and manic exacerbations ("switches"). We also measured side effects and bleeding time, a biomarker of drug action.Results Overall, there were no significant differences on any outcome measure between the EPA and placebo groups.Conclusions This study did not find overall evidence of efficacy for adjunctive treatment with EPA 6 g/day in outpatients with bipolar depression or rapid cycling bipolar disorder.
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In patients with bipolar disorder, ethyl eicosapentaenoic acid (6 g/day) showed no significant differences from placebo for depressive and manic symptoms.
“No significant differences between the ethyl eicosapentaenoic acid and placebo groups have been found.”
From Reactive Oxygen Species, Toxicity, Oxidative Stress, and Antioxidants: Chronic Diseases and Aging (2023) · cites this paper as Keck et al. 2006
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- Authors
- Keck, P. E., Mintz, J., McElroy, S. L., Freeman, M. P., Suppes, T., Frye, M. A., Altshuler, L. L., Kupka, R., Nolen, W. A., Leverich, G. S., Denicoff, K. D., Grunze, H., Duan, N., & Post, R. M.
- Affiliations
- Cincinnati VA Medical Center (US)
- University of California, Los Angeles (US)
- University of Cincinnati (US)
- University of Arizona (US)
- The University of Texas Southwestern Medical Center (US)
- University Medical Center Utrecht (NL)
- University Medical Center Groningen (NL)
- National Institutes of Health (US)
- Ludwig-Maximilians-Universität München (DE)
- Corresponding author
- Keck, Paul E.
- ORCID
- Venue
- Biological Psychiatry
- Publisher
- Elsevier BV
- Published
- 2006-11
- Volume
- 60
- Issue
- 9
- Pages
- 1020-1022
- ISSN
- 0006-3223 (ISSN-L)
- OpenAlex
- W2054486548
- Cited by
- 234
- References
- 21
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 1 · 2023: 2 · 2022: 4 · 2021: 7 · 2020: 11 · 2019: 9 · 2018: 8 · 2017: 10 · 2016: 18 · 2015: 11 · 2014: 11 · 2013: 15 · 2012: 16
- FWCI
- 15.27
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Biological Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Funders
- National Alliance for Research on Schizophrenia and Depression
- Stanley Medical Research Institute
- American Psychiatric Association
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Keywords
- omega-3 fatty acids, bipolar depression, rapid cycling bipolar disorder, adjunctive therapy, mood stabilizers, manic symptoms, bleeding time, antidepressant efficacy
- MeSH terms
- Adult, Antidepressive Agents, Bipolar Disorder, Double-Blind Method, Female, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Eicosapentaenoic Acid, Treatment Outcome
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