1. A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials
- Author
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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 WJH, 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 JG, 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, and Pariante, Carmine M
- Subjects
Clinical Trials and Supportive Activities ,Depression ,Clinical Research ,Mental Health ,Brain Disorders ,Serious Mental Illness ,Major Depressive Disorder ,Good Health and Well Being ,Depressive Disorder ,Major ,Depressive Disorder ,Treatment-Resistant ,Humans ,Biological Sciences ,Medical and Health Sciences ,Psychology and Cognitive Sciences ,Psychiatry - Abstract
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.
- Published
- 2022