Methodological and reporting recommendations for clinical trials in Nutritional Psychiatry: guidelines from the International Society for Nutritional Psychiatry Research

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dc.contributor.authorMarx, Wolfgang
dc.contributor.authorVisser, Marjolein
dc.contributor.authorWallace, Caroline
dc.contributor.authorJacka, Felice N.
dc.contributor.authorBayes, Jessica
dc.contributor.authorFrancis, Heather
dc.contributor.authorOpie, Rachelle
dc.contributor.authorHockey, Meghan
dc.contributor.authorTeasdale, Scott B.
dc.contributor.authorSánchez Villegas, María Almudena
dc.contributor.authorO'Neil, Adrienne
dc.contributor.authorSu, Kuan-Pin
dc.contributor.authorRucklidge, Julia J.
dc.contributor.authorBerk, Michael
dc.contributor.authorLopresti, Adrian
dc.contributor.authorMischoulon, David
dc.contributor.authorJohnstone, Jeanette M.
dc.contributor.authorStaudacher, Heidi M.
dc.contributor.departmentCiencias de la Saludes_ES
dc.contributor.departmentOsasun Zientziakeu
dc.contributor.departmentInstitute on Innovation and Sustainable Development in Food Chain - ISFOODen
dc.date.accessioned2025-02-24T09:23:58Z
dc.date.available2025-02-24T09:23:58Z
dc.date.issued2024-12-10
dc.date.updated2025-02-24T09:15:08Z
dc.description.abstractResearch on nutraceutical and dietary interventions in psychiatry has grown substantially, but progress is hindered by methodological inconsistencies and limited reporting standards. To address this, the International Society for Nutritional Psychiatry Research presents the first guidelines on clinical trial design, conduct, and reporting for future clinical trials in this area. Recommendations were developed using a Delphi process including eighteen researchers with considerable clinical trial expertise and experience in either methodology, nutraceutical, or dietary interventions in psychiatry. These guidelines provide forty-nine recommendations for clinical trial design and outcomes, five for trial reporting, and seven for future research priorities. The recommendations included in these guidelines are designed to inform both nutraceutical and dietary clinical trial interventions in Nutritional Psychiatry. Common themes include an emphasis on the importance of a multidisciplinary research team and integration of co-design processes into the conduct and design of clinical research, methods to improve transparency and replicability of trial outcomes, and measures to address common biases in nutrition trials. Furthermore, we provide recommendations for future research including examining a greater variety of nutraceutical and dietary interventions, scalable delivery models, effectiveness and implementation studies, and the need to investigate these interventions in the prevention and management of less studied psychiatric conditions (e.g. schizophrenia and bipolar disorder). Recommendations included within these guidelines are intended to improve the rigor and clinical relevance of ongoing and future clinical trials in Nutritional Psychiatry.en
dc.description.sponsorshipM. B. is supported by a NHMRC Senior Principal Research Fellowship and Leadership 3 Investigator grant (1156072 and 2017131). A. O. is supported by National Health & Medical Research Council Emerging Leader 2 Fellowship (2009295). S. T. is supported by a National Health & Medical Research Council Emerging Leader 1 Fellowship (2017302). D. M. has received research support from Nordic Naturals and Heckel Medizintechnik GmbH. He has received honoraria for speaking from the Massachusetts General Hospital Psychiatry Academy, Peerpoint Medical Education Institute, LLC and Harvard blog. He also works with the MGH Clinical Trials Network and Institute (CTNI), which has received research funding from multiple pharmaceutical companies and NIMH. K.-P.S. has been a speaker and/or consultant for Johnson & Johnson, AstraZeneca, Lundbeck, Eli Lilly, Merck, Pfizer, Servier, Otsuka, Excelsior Biopharma, Chen Hua Biotech, Nutrarex Biotech and Hoan Pharmaceuticals. H. M. S. is currently funded by a National Health & Meical Research Council Emerging Leader Fellowship (2018118) and has received research funding from DSM Pharmaceuticals and VSL Pharmaceuticals, non-financial support from VSL Pharmaceuticals, consulting fees from Dietitian Connection, Dietitians Australia and Microba.
dc.format.mimetypeapplication/pdfen
dc.format.mimetypeapplication/msworden
dc.identifier.citationMarx, W., Visser, M., Wallace, C., Jacka, F. N., Bayes, J., Francis, H., Opie, R., Hockey, M., Teasdale, S. B., Sanchez Villegas, A., O'Neil, A., Su, K. P., Rucklidge, J. J., Berk, M., Lopresti, A., Mischoulon, D., Johnstone, J. M., Staudacher, H. M. (2024). Methodological and reporting recommendations for clinical trials in Nutritional Psychiatry: guidelines from the International Society for Nutritional Psychiatry Research. British Journal of Nutrition, 1-13. https://doi.org/10.1017/S0007114524001946.
dc.identifier.doi10.1017/S0007114524001946
dc.identifier.issn0007-1145
dc.identifier.urihttps://academica-e.unavarra.es/handle/2454/53542
dc.language.isoeng
dc.publisherCambridge University Press
dc.relation.ispartofBritish Journal of Nutrition (2024)
dc.relation.publisherversionhttps://doi.org/10.1017/S0007114524001946
dc.rights© The Author(s), 2024. Published by Cambridge University Press on behalf of The Nutrition Society. This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence.
dc.rights.accessRightsinfo:eu-repo/semantics/openAccess
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectClinical trialsen
dc.subjectGuidelinesen
dc.subjectMental healthen
dc.subjectNutritional psychiatryen
dc.titleMethodological and reporting recommendations for clinical trials in Nutritional Psychiatry: guidelines from the International Society for Nutritional Psychiatry Researchen
dc.typeinfo:eu-repo/semantics/article
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dspace.entity.typePublication
relation.isAuthorOfPublicationae8afd07-1f10-4da5-8582-93b90a18aa88
relation.isAuthorOfPublication.latestForDiscoveryae8afd07-1f10-4da5-8582-93b90a18aa88

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