A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials
Sforzini, Luca (King's College London)
Worrell, Courtney (King's College London)
Kose, Melisa (King's College London)
Anderson, Ian M. (The University of Manchester and Manchester Academic Health Sciences Centre)
Aouizerate, Bruno (University of Bordeaux)
Arolt, Volker (University of Münster)
Bauer, Michael (University Hospital Carl Gustav Carus)
Baune, Bernhard T. (The University of Melbourne)
Cleare, Anthony J. (National Institute for Health Research Mental Health Biomedical Research Centre)
Cowen, Philip J. (University of Oxford)
Dinan, Timothy G. (University College Cork)
Fagiolini, Andrea (University of Siena)
Ferrier, I. Nicol (Newcastle University)
Hegerl, Ulrich (Goethe University)
Krystal, Andrew D. (Duke University School of Medicine)
Leboyer, Marion (Université Paris Est Creteil (UPEC))
McAllister-Williams, R. Hamish (Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust)
McIntyre, Roger S. (Brain and Cognition Discovery Foundation)
Meyer-Lindenberg, Andreas (Heidelberg University)
Miller, Andrew H. (Emory University School of Medicine)
Nemeroff, Charles B. (University of Texas at Austin)
Normann, Claus (Medical Center - University of Freiburg)
Nutt, David (Imperial College)
Pallanti, Stefano (University of Florence)
Pani, Luca (VeraSci)
Penninx, Brenda W. J. H. (Vrije Universiteit and GGZinGeest)
Schatzberg, Alan F. (Stanford University)
Shelton, Richard C. (University of Alabama at Birmingham)
Yatham, Lakshmi N. (University of British Columbia)
Young, Allan H. (National Institute for Health Research Mental Health Biomedical Research Centre)
Zahn, Roland (National Institute for Health Research Mental Health Biomedical Research Centre)
Aislaitner, Georgios (Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM))
Butlen-Ducuing, Florence (European Medicines Agency)
Fletcher, Christine (Biostatistics, GlaxoSmithKline)
Haberkamp, Marion (Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM))
Laughren, Thomas (Laughren Psychopharm Consulting)
Mäntylä, Fanni-Laura (GAMIAN-Europe (Global Alliance of Mental Illness Advocacy Networks-Europe))
Schruers, Koen (University of Leuven)
Thomson, Andrew (European Medicines Agency)
Arteaga-Henríquez, Gara (Hospital Universitari Vall d'Hebron)
Benedetti, Francesco (IRCCS Scientific Institute Ospedale San Raffaele)
Cash-Gibson, Lucinda (Hospital Universitari Vall d'Hebron)
Chae, Woo Ri (Charité - Universitätsmedizin Berlin)
De Smedt, Heidi (Janssen Research & Development)
Gold, Stefan M. (University Medical Center Hamburg-Eppendorf)
Hoogendijk, Witte J. G. (Erasmus University Medical Centre)
Mondragón, Valeria Jordán (Medical Director Neuroscience for Region Europe at Novartis Pharma)
Maron, Eduard (West Tallinn Central Hospital)
Martynowicz, Jadwiga (Janssen Research & Development)
Melloni, Elisa (IRCCS Scientific Institute Ospedale San Raffaele)
Otte, Christian (Charité - Universitätsmedizin Berlin)
Perez-Fuentes, Gabriela (Hospital Universitari Vall d'Hebron)
Poletti, Sara (IRCCS Scientific Institute Ospedale San Raffaele)
Schmidt, Mark E. (Janssen Pharmaceutica NV)
van de Ketterij, Edwin (European Infrastructure for Translational Medicine (EATRIS))
Woo, Katherine (Janssen Research & Development)
Flossbach, Yanina (Novartis Pharma AG)
Ramos-Quiroga, Josep Antoni (Hospital Universitari Vall d'Hebron)
Savitz, Adam J. (Department of Neuroscience)
Pariante, Carmine M (National Institute for Health Research Mental Health Biomedical Research Centre)
Universitat Autònoma de Barcelona

Data:	2021
Resum:	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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Depression ; Diagnostic markers
Publicat a:	Molecular psychiatry, Vol. 27 (december 2021) , p. 1286-1299, ISSN 1476-5578

DOI: 10.1038/s41380-021-01381-x
PMID: 34907394

14 p, 1.3 MB

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