TY - JOUR
T1 - A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials
AU - Sforzini, Luca
AU - Worrell, Courtney
AU - Kose, Melisa
AU - Anderson, Ian M
AU - Aouizerate, Bruno
AU - Arolt, Volker
AU - Bauer, Michael
AU - Baune, Bernhard T
AU - Blier, Pierre
AU - Cleare, Anthony J
AU - Cowen, Philip J
AU - Dinan, Timothy G
AU - Fagiolini, Andrea
AU - Ferrier, I Nicol
AU - Hegerl, Ulrich
AU - Krystal, Andrew D
AU - Leboyer, Marion
AU - McAllister-Williams, R Hamish
AU - McIntyre, Roger S
AU - Meyer-Lindenberg, Andreas
AU - Miller, Andrew H
AU - Nemeroff, Charles B
AU - Normann, Claus
AU - Nutt, David
AU - Pallanti, Stefano
AU - Pani, Luca
AU - Penninx, Brenda W J H
AU - Schatzberg, Alan F
AU - Shelton, Richard C
AU - Yatham, Lakshmi N
AU - Young, Allan H
AU - Zahn, Roland
AU - Aislaitner, Georgios
AU - Butlen-Ducuing, Florence
AU - Fletcher, Christine
AU - Haberkamp, Marion
AU - Laughren, Thomas
AU - Mäntylä, Fanni-Laura
AU - Schruers, Koen
AU - Thomson, Andrew
AU - Arteaga-Henríquez, Gara
AU - Benedetti, Francesco
AU - Cash-Gibson, Lucinda
AU - Chae, Woo Ri
AU - De Smedt, Heidi
AU - Gold, Stefan M
AU - Hoogendijk, Witte J G
AU - Mondragón, Valeria Jordán
AU - Maron, Eduard
AU - Pariante, Carmine M
N1 - 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).
PY - 2021/12/15
Y1 - 2021/12/15
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85121294632&partnerID=8YFLogxK
U2 - 10.1038/s41380-021-01381-x
DO - 10.1038/s41380-021-01381-x
M3 - Article
C2 - 34907394
SN - 1359-4184
JO - Molecular Psychiatry
JF - Molecular Psychiatry
ER -