Molecular psychiatry · 2021

A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials.

Consensus StatementСтатьяПоддержка исследования: вне правительства СШАОбзорНазвание и аннотация: Перевод в очереди

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Sforzini Luca, Worrell Courtney, Kose Melisa, Anderson Ian M, Aouizerate Bruno, Arolt Volker, Bauer Michael, Baune Bernhard T, Blier Pierre, Cleare Anthony J, Cowen Philip J, Dinan Timothy G, Fagiolini Andrea, Ferrier I Nicol, Hegerl Ulrich, Krystal Andrew D, Leboyer Marion, McAllister-Williams R Hamish, McIntyre Roger S, Meyer-Lindenberg Andreas, Miller Andrew H, Nemeroff Charles B, Normann Claus, Nutt David, Pallanti Stefano, Pani Luca, Penninx Brenda W J H, Schatzberg Alan F, Shelton Richard C, Yatham Lakshmi N, Young Allan H, Zahn Roland, Aislaitner Georgios, Butlen-Ducuing Florence, Fletcher Christine, Haberkamp Marion, Laughren Thomas, Mäntylä Fanni-Laura, Schruers Koen, Thomson Andrew, Arteaga-Henríquez Gara, Benedetti Francesco, Cash-Gibson Lucinda, Chae Woo Ri, De Smedt Heidi, Gold Stefan M, Hoogendijk Witte J G, Mondragón Valeria Jordán, Maron Eduard, Martynowicz Jadwiga, Melloni Elisa, Otte Christian, Perez-Fuentes Gabriela, Poletti Sara, Schmidt Mark E, van de Ketterij Edwin, Woo Katherine, Flossbach Yanina, Ramos-Quiroga J Antoni, Savitz Adam J, Pariante Carmine M

Аннотация

Criteria 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.

Предметные рубрики MeSH

Humans Adaptive Clinical Trials as Topic Depression Depressive Disorder, Treatment-Resistant Major Depressive Disorder

A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials.

Ошибки и ограничения

Аннотация

Предметные рубрики MeSH