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

• Type of Material: Article
• Authors: Luca Sforzini, King’s College London; Courtney Worrell, King’s College London; Melisa Kose, King’s College London; Ian M Anderson, University of Manchester; Bruno Aouizerate, University of Bordeaux; Volker Arolt, University of Munster; Michael Bauer, Technische Universitat Dresden; Bernhard T Baune, University of Munster; Pierre Blier, Royal’s Institute of Mental Health Research; Anthony J Cleare, King’s College London; Philip J Cowen, University of Oxford; Timothy G Dinan, APC Microbiome Ireland; Andrea Fagiolini, University of Siena; Newcastle University Ferrier, Newcastle University; Ulrich Hegerl, Goethe University; Andrew D Krystal, University of California San Francisco; Marion Leboyer, Univ Paris Est Creteil UPEC; Hamish R McAllister-Williams, Newcastle University; Roger S McIntyre, University of Toronto; Andreas Meyer-Lindenberg, Heidelberg Univ; Andrew Miller, Emory University; Charles B Nemeroff, University of Texas Austin; Claus Normann, University of Freiburg; David Nutt, Imperial College London; Stefano Pallanti, University of Florence; Luca Pani, Psychiatry University of Miami; Brenda WJH Penninx, Vrije Universiteit and GGZinGeest; Alan F Schatzberg, Stanford University; Richard C Shelton, University of Alabama Birmingham; Lakshmi N Yatham, University of British Columbia; Allan H Young, King’s College London; Roland Zahn, King’s College London; Georgios Aislaitner, Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM; Florence Butlen-Ducuing, European Medicines Agency; Christine Fletcher, GlaxoSmithKline; Marion Haberkamp, Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM; Thomas Laughren, Laughren Psychopharm Consulting LLC; Fanni-Laura Mäntylä, GAMIAN Europe Global Alliance Mental Illness Advo; Koen Schruers, Maastricht University; Andrew Thomson, European Medicines Agency; Gara Arteaga-Henriquez, Hospital Universitari Vall d’Hebron (HUVH); Francesco Benedetti, Vita-Salute San Raffaele University; Lucinda Cash-Gibson, Vall d ‘Hebron Research Institute (VHIR); Woo Ri Chae, Charité – Universitätsmedizin Berlin; Heidi De Smedt, Janssen Research & Development, Beerse; Stefan M Gold, Charité – Universitätsmedizin Berlin; Witte JG Hoogendijk, Erasmus MC; Valeria J Mondragon, Novartis Pharmaceut; Eduard Maron, University of Tartu; Jadwiga Martynowicz, Janssen Res & Dev LLC; Elisa Melloni, Univ Vita Salute San Raffaele; Christian Otte, Charité – Universitätsmedizin Berlin; Gabriela Perez-Fuentes, Vall d’Hebron Research Institute (VHIR); Sara Poletti, IRCCS Sci Inst Osped San Raffaele; Mark E Schmidt, Janssen Pharmaceutica NV; Edwin van de Ketterij, European Infrastruct Translat Med EATRIS; Katherine Woo, Janssen Research & Development, LLC; Yanina Flossbach, Novartis Pharma AG; Antoni J Ramos-Quiroga, Hospital Universitari Vall d’Hebron (HUVH); Adam J Savitz, Janssen Research & Development, LLC; Carmine M Pariante, King’s College London
• Language: English
• Date: 2021-12-15
• Publisher: SPRINGERNATURE
• Publication Version: Final Published Version
• Copyright Statement: © The Author(s) 2021
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1038/s41380-021-01381-x
• Title of Journal or Parent Work: MOLECULAR PSYCHIATRY
• Volume: 27
• Issue: 3
• Start Page: 1286
• End Page: 1299
• Keywords: SEROTONIN REUPTAKE INHIBITORS; STAR-ASTERISK-D; Science & Technology; METAANALYSIS; Neurosciences; QUICK INVENTORY; STIMULATION; SYMPTOMATOLOGY; Life Sciences & Biomedicine; Neurosciences & Neurology; Biochemistry & Molecular Biology; REMISSION; REPORT QIDS-SR; DISORDER; Psychiatry; RATING-SCALE
• Research Categories: Health Sciences, Pharmacology; Engineering, Biomedical

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.