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

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

doi:10.1038/s41380-021-01381-x

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

Journal article

Peer reviewed

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

Luca Sforzini, Courtney Worrell, Melisa Kose, Ian M Anderson, Bruno Aouizerate, Volker Arolt, Michael Bauer, Bernhard T Baune, Pierre Blier, Anthony J Cleare, …

Molecular psychiatry, Vol.27(3), pp.1286-1299

2022-03

DOI: https://doi.org/10.1038/s41380-021-01381-x

PMID: 34907394

Appears in Miller School of Medicine - Latest Publications

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.

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Collaboration types: Industry collaboration; Domestic collaboration; International collaboration
Citation topics: 1 Clinical & Life Sciences; 1.21 Psychiatry; 1.21.35 Depression
Web Of Science research areas: Biochemistry & Molecular Biology; Neurosciences; Psychiatry
ESI research areas: Neuroscience & Behavior

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Title: A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials
Creators: Luca Sforzini - King's College London
Courtney Worrell - King's College London
Melisa Kose - King's College London
Ian M Anderson - Manchester Academic Health Science Centre
Bruno Aouizerate - University of Bordeaux
Volker Arolt - University of Münster
Michael Bauer - University Hospital Carl Gustav Carus
Bernhard T Baune - University of Münster
Pierre Blier - Royal Ottawa Mental Health Centre
Anthony J Cleare - King's College London
Philip J Cowen - University of Oxford
Timothy G Dinan
Andrea Fagiolini - University of Siena
I Nicol Ferrier - Newcastle University
Ulrich Hegerl - European Alliance Against Depression
Andrew D Krystal - University of California, San Francisco
Marion Leboyer - Université Paris Est Creteil (UPEC), AP-HP, Hôpitaux Universitaires Henri Mondor, Département Médico-Universitaire d’Addictologie et Psychiatrie (DMU IMPACT), INSERM U955, IMRB, translational Neuropsychiatry lab, Fondation FondaMental
R Hamish McAllister-Williams - Newcastle University
Roger S McIntyre - University of Toronto
Andreas Meyer-Lindenberg - Heidelberg University
Andrew H Miller - Emory University
Charles B Nemeroff - Department of Psychiatry, University of Texas at Austin, Dell Medical School, Austin, TX, USA
Claus Normann - University of Freiburg
David Nutt - Imperial College London
Stefano Pallanti - University of Florence
Luca Pani - University of Miami
Brenda W J H Penninx - Vrije Universiteit Amsterdam
Alan F Schatzberg - Stanford University
Richard C Shelton - University of Alabama at Birmingham
Lakshmi N Yatham - University of British Columbia
Allan H Young - King's College London
Roland Zahn - King's College London
Georgios Aislaitner - Federal Institute for Drugs and Medical Devices
Florence Butlen-Ducuing - European Medicines Agency
Christine Fletcher - GlaxoSmithKline
Marion Haberkamp - Federal Institute for Drugs and Medical Devices
Thomas Laughren - Product Innovation and Engineering (United States, Saint James) - LLC
Fanni-Laura Mäntylä - Global Alliance of Mental Illness Advocacy Networks-Europe
Koen Schruers - Maastricht University Medical Centre
Andrew Thomson - European Medicines Agency
Gara Arteaga-Henríquez - Vall d'Hebron Hospital Universitari
Francesco Benedetti - Vita-Salute San Raffaele University
Lucinda Cash-Gibson - Vall d'Hebron Institut de Recerca
Woo Ri Chae - Charité - Universitätsmedizin Berlin
Heidi De Smedt - Janssen
Stefan M Gold - Charité - Universitätsmedizin Berlin
Witte J G Hoogendijk - Erasmus MC
Valeria Jordán Mondragón - Novartis
Eduard Maron - University of Tartu
Jadwiga Martynowicz - Janssen
Elisa Melloni - Vita-Salute San Raffaele University
Christian Otte - Charité - Universitätsmedizin Berlin
Gabriela Perez-Fuentes - Vall d'Hebron Institut de Recerca
Sara Poletti - IRCCS Ospedale San Raffaele
Mark E Schmidt - Janssen
Edwin van de Ketterij - European Infrastructure for Translational Medicine (EATRIS)
Katherine Woo - Janssen
Yanina Flossbach - Novartis
J Antoni Ramos-Quiroga - Biomedical Network Research Centre on Mental Health (CIBERSAM), Barcelona, Catalonia, Spain
Adam J Savitz - Janssen
Carmine M Pariante - King's College London
Publication Details: Molecular psychiatry, Vol.27(3), pp.1286-1299
Grant note: MR/S003037/1 / Medical Research Council 853966 / Innovative Medicines Initiative (IMI)
Academic Unit: Miller School of Medicine; UMMG Dept of Psychiatry & Behavioral Sciences
Language: English
Resource Type: Journal article
PMID: 34907394
Record Identifier: 991031723498602976