Kiki P van der Burg1, Lachlan Cribb2, Chee H Ng2, Joseph Firth3,4, Diana Karmacoska3, David Mischoulon5, Gerard J Byrne6, Chad Bousman7,8, Con Stough9, Jenifer Murphy2, Georgina Oliver2, Michael Berk8,10,11,12, Jerome Sarris13,14. 1. MaSc Medicine at University Medical Center Utrecht (UMCU), Utrecht, The Netherlands. 2. Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Melbourne, Australia. 3. NICM Health Research Institute, Western Sydney University, Westmead, Australia. 4. Division of Psychology and Mental Health, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK. 5. Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. 6. Faculty of Medicine, Discipline of Psychiatry, Centre for Clinical Research, Royal Brisbane and Women's Hospital, The University of Queensland, Herston, Australia. 7. Departments of Medical Genetics, Psychiatry, and Physiology and Pharmacology, University of Calgary, Calgary, AB, Canada. 8. Department of Psychiatry, The University of Melbourne, Melbourne, Australia. 9. Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn, Australia. 10. IMPACT SRC, Barwon Health, School of Medicine, Deakin University, Geelong, Australia. 11. Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Parkville, Australia. 12. Orygen, The Centre of Excellence in Youth Mental Health, The University of Melbourne, Parkville, Australia. 13. Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne, Melbourne, Australia. j.sarris@westernsydney.edu.au. 14. NICM Health Research Institute, Western Sydney University, Westmead, Australia. j.sarris@westernsydney.edu.au.
Abstract
PURPOSE: Depression clinical trials are increasingly studying biomarkers to predict and monitor response to treatment. Assessment of biomarkers may reveal subsets of patients who are responsive to nutraceutical treatment, which may facilitate a personalized approach to treating depression. METHODS: This is a post hoc analysis of an 8-week, double-blind, randomized, controlled trial (n = 158) investigating a combination nutraceutical comprising Omega-3 (EPA 1 g/DHA 656 mg), SAMe, zinc, 5-HTP, folinic acid, and co-factors versus placebo for the treatment of Major Depressive Disorder. The study explored levels of polyunsaturated fatty acids, folate, vitamin B12, zinc, homocysteine, and BDNF as possible predictors and correlates of response to nutraceutical supplementation. RESULTS:Concentrations of EPA and DHA in red cell membranes increased in response to treatment and were significantly correlated with a decrease in depressive symptoms during active treatment (p = 0.003 and p = 0.029; respectively). Higher baseline levels of omega-6 fatty acid also correlated with depression reduction in the active treatment group ( p = 0.011). No other biomarkers were associated with a lessening of depressive symptoms. CONCLUSION: Changes in fatty acid levels resulting from a nutraceutical combination containing EPA and DHA provide a response biomarker in treating depression.
RCT Entities:
PURPOSE:Depression clinical trials are increasingly studying biomarkers to predict and monitor response to treatment. Assessment of biomarkers may reveal subsets of patients who are responsive to nutraceutical treatment, which may facilitate a personalized approach to treating depression. METHODS: This is a post hoc analysis of an 8-week, double-blind, randomized, controlled trial (n = 158) investigating a combination nutraceutical comprising Omega-3 (EPA 1 g/DHA 656 mg), SAMe, zinc, 5-HTP, folinic acid, and co-factors versus placebo for the treatment of Major Depressive Disorder. The study explored levels of polyunsaturated fatty acids, folate, vitamin B12, zinc, homocysteine, and BDNF as possible predictors and correlates of response to nutraceutical supplementation. RESULTS: Concentrations of EPA and DHA in red cell membranes increased in response to treatment and were significantly correlated with a decrease in depressive symptoms during active treatment (p = 0.003 and p = 0.029; respectively). Higher baseline levels of omega-6 fatty acid also correlated with depression reduction in the active treatment group ( p = 0.011). No other biomarkers were associated with a lessening of depressive symptoms. CONCLUSION: Changes in fatty acid levels resulting from a nutraceutical combination containing EPA and DHA provide a response biomarker in treating depression.
Entities:
Keywords:
Biomarker; Depression; Nutraceutical; Omega-3; Precision medicine
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