A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials
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Published:2021-12-15
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ISSN:1359-4184
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Container-title:Molecular Psychiatry
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language:en
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Short-container-title:Mol Psychiatry
Author:
Sforzini LucaORCID, Worrell CourtneyORCID, Kose Melisa, Anderson Ian M., Aouizerate Bruno, Arolt Volker, Bauer MichaelORCID, Baune Bernhard T., Blier Pierre, Cleare Anthony J.ORCID, Cowen Philip J.ORCID, Dinan Timothy G.ORCID, Fagiolini Andrea, Ferrier I. Nicol, Hegerl Ulrich, Krystal Andrew D.ORCID, Leboyer MarionORCID, McAllister-Williams R. Hamish, McIntyre Roger S., Meyer-Lindenberg Andreas, Miller Andrew H.ORCID, Nemeroff Charles B.ORCID, Normann ClausORCID, Nutt DavidORCID, Pallanti Stefano, Pani Luca, Penninx Brenda W. J. H., Schatzberg Alan F., Shelton Richard C., Yatham Lakshmi N., Young Allan H.ORCID, Zahn Roland, Aislaitner Georgios, Butlen-Ducuing Florence, Fletcher Christine, Haberkamp Marion, Laughren Thomas, Mäntylä Fanni-Laura, Schruers Koen, Thomson Andrew, Arteaga-Henríquez Gara, Benedetti FrancescoORCID, Cash-Gibson Lucinda, Chae Woo RiORCID, De Smedt Heidi, Gold Stefan M.ORCID, Hoogendijk Witte J. G., Mondragón Valeria Jordán, Maron Eduard, Martynowicz Jadwiga, Melloni Elisa, Otte ChristianORCID, Perez-Fuentes Gabriela, Poletti SaraORCID, Schmidt Mark E., van de Ketterij EdwinORCID, Woo Katherine, Flossbach Yanina, Ramos-Quiroga J. AntoniORCID, Savitz Adam J., Pariante Carmine M.ORCID
Abstract
AbstractCriteria for treatment-resistant depression (TRD) and partially responsive depression (PRD) as subtypes of major depressive disorder (MDD) are not unequivocally defined. In the present document we used a Delphi-method-based consensus approach to define TRD and PRD and to serve as operational criteria for future clinical studies, especially if conducted for regulatory purposes. We reviewed the literature and brought together a group of international experts (including clinicians, academics, researchers, employees of pharmaceutical companies, regulatory bodies representatives, and one person with lived experience) to evaluate the state-of-the-art and main controversies regarding the current classification. We then provided recommendations on how to design clinical trials, and on how to guide research in unmet needs and knowledge gaps. This report will feed into one of the main objectives of the EUropean Patient-cEntric clinicAl tRial pLatforms, Innovative Medicines Initiative (EU-PEARL, IMI) MDD project, to design a protocol for platform trials of new medications for TRD/PRD.
Funder
Innovative Medicines Initiative
Publisher
Springer Science and Business Media LLC
Subject
Cellular and Molecular Neuroscience,Psychiatry and Mental health,Molecular Biology
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