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

2022-03

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 W J H

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 J G

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

Pariante, Carmine M

Journal Article

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10.1038/s41380-021-01381-x

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.

link

Molecular Psychiatry 2022; 27(3): 1286-1299

Molecular Psychiatry