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

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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 & 30 more 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, Carmine M Pariante

Original languageEnglish
JournalMolecular Psychiatry
DOIs
E-pub ahead of print15 Dec 2021

Bibliographical note

Funding Information: The EU-PEARL Project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853966. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and CHILDREN’S TUMOR FOUNDATION, GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT NON-PROFIT ORGANISATION, SPRINGWORKS THERAPEUTICS INC. Publisher Copyright: © 2021, The Author(s).

King's Authors

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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