Journal article

Nutraceuticals for major depressive disorder- more is not merrier: An 8-week double-blind, randomised, controlled trial

Jerome Sarris, Gerard J Byrne, Con Stough, Chad Bousman, David Mischoulon, Jenifer Murphy, Patricia Macdonald, Laura Adams, Sonia Nazareth, Georgina Oliver, Lachlan Cribb, Karen Savage, Ranjit Menon, Suneel Chamoli, Michael Berk, Chee H Ng



BACKGROUND: One of the most pressing questions in "Nutritional Psychiatry" is whether using combinations of different nutraceuticals with putative antidepressant activity may provide an enhanced synergistic antidepressant effect. METHODS: A phase II/III, Australian multi-site, 8-week, double-blind, RCT involving 158 outpatients with a DSM-5 diagnosis of MDD. The intervention consisted of a nutraceutical combination: S-adenosyl methionine; Folinic acid; Omega-3 fatty acids; 5-HTP, Zinc picolinate, and relevant co-factors versus placebo. The primary outcome was change in MADRS score. Hypothesis-driven analyses of potential moderators of response involving key SNPs, and BDNF were also conducted..

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Awarded by Australian National Health and Medical Research Council

Awarded by NHMRC Fellowship

Awarded by NHMRC Senior Principal Research Fellowship

Funding Acknowledgements

This grant is funded by an Australian National Health and Medical Research Council project grant (APP1048222), and is co-sponsored by FIT-BioCeuticals (who provided the trial product and placebo). Jerome Sarris is supported by an NHMRC Fellowship (APP1125000). Michael Berk is supported by a NHMRC Senior Principal Research Fellowship (1059660 and 1156072). BioCeuticals was not involved in any aspect of study design, analysis, manuscript preparation or the decision to submit this manuscript for publication.