Please use this identifier to cite or link to this item:
https://ahro.austin.org.au/austinjspui/handle/1/30231| Title: | A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials. | Austin Authors: | 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 | Affiliation: | The Florey Institute of Neuroscience and Mental Health Albert Einstein College of Medicine, New York, USA APC Microbiome Ireland, Cork, Ireland Biomedical Network Research Centre on Mental Health (CIBERSAM), Barcelona, Catalonia, Spain Biomedical Network Research Centre on Mental Health (CIBERSAM), Madrid, Spain Biostatistics, GlaxoSmithKline, London, UK Brain and Cognition Discovery Foundation, Toronto, ON, Canada Centre for Neuropsychopharmacology, Division of Psychiatry, Imperial College, London, London, UK Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Berlin, Germany Charité - Universitätsmedizin Berlin, Department of Psychosomatic Medicine, Campus Benjamin Franklin, Berlin, Germany Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, UK Data, Analytics and Methodology Taskforce, European Medicines Agency, Amsterdam, the Netherlands Department for Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstrasse 5, 79104, Freiburg, Germany Department of Biomedical, Metabolic & Neural Sciences, University of Modena, Modena, Italy Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, ON, Canada Department of General and Academic Psychiatry, Centre Hospitalier Charles Perrens, Laboratory of Nutrition and Integrative Neurobiology (UMR INRAE 1286), University of Bordeaux, Bordeaux, France Department of Global Regulatory Affairs, Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA Department of Molecular Medicine, Division of Psychiatry, University of Siena, Siena, Italy Department of Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA Department of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, 30322, USA Department of Psychiatry and Behavioral Sciences, Psychiatry University of Miami, Miami, FL, USA Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA Department of Psychiatry and Forensic Medicine, Universitat Autònoma de Barcelona, Barcelona, Catalonia, Spain Department of Psychiatry and Neurobehavioral Sciences, University College Cork, Cork, Ireland Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Square J5, 68159, Mannheim, Germany Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Medical Faculty, Technische Universität Dresden, Dresden, Germany Department of Psychiatry and Psychotherapy, University of Münster, Münster, Germany Department of Psychiatry, Amsterdam UMC, Vrije Universiteit and GGZinGeest, Amsterdam, the Netherlands Department of Psychiatry, Erasmus University Medical Centre, Rotterdam, the Netherlands Department of Psychiatry, Hospital Universitari Vall d'Hebron (HUVH), Barcelona, Catalonia, Spain Department of Psychiatry, Melbourne Medical School, The University of Melbourne, Parkville, VIC, Australia Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USA Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada Department of Psychiatry, University of Tartu, Tartu, Estonia Department of Psychiatry, University of Texas at Austin, Dell Medical School, Austin, TX, USA Department of Psychiatry, University of Toronto, Toronto, ON, Canada Depression Research Center of the German Depression Foundation and Department of Psychiatry, Psychosomatics and Psychotherapy, Goethe University, Frankfurt, Germany Division of Neuroscience, Psychiatry and Clinical Psychobiology, IRCCS Scientific Institute Ospedale San Raffaele, Milan, Italy Documental Ltd, Tallin, Estonia European Infrastructure for Translational Medicine (EATRIS), Amsterdam, Netherlands Experimental Medicine, Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium Faculty of Medicine, Department of Medicine, Centre for Neuropsychopharmacology, Division of Brain Sciences, Imperial College London, London, UK Faculty of Psychology, Center for Experimental and Learning Psychology, University of Leuven, Leuven, Belgium Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Bonn, Germany GAMIAN-Europe (Global Alliance of Mental Illness Advocacy Networks-Europe), Brussels, Belgium Group of Psychiatry, Mental Health and Addictions, Vall d'Hebron Research Institute (VHIR), Barcelona, Catalonia, Spain Istituto di Neuroscience, University of Florence, Italy Janssen Research & Development, Beerse, Belgium King's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK Laughren Psychopharm Consulting, LLC, Rockville, MD, USA Manchester Academic Health Sciences Centre, Manchester, UK Maudsley NHS Foundation Trust and King's College London, London, UK Medical Director Neuroscience for Region Europe at Novartis Pharma, Basel, Switzerland Medical Sciences Division, Department of Psychiatry, University of Oxford, Oxford, UK Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada National Institute for Health Research Mental Health Biomedical Research Centre, South London, UK Neuroscience and Psychiatry Unit, Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biological, Medical and Human Sciences, The University of Manchester, Manchester, UK Neuroscience, Global Drug Development, Novartis Pharma AG, Basel, Switzerland Office of Therapies for Neurological and Psychiatric disorders, Human Medicines Division, European Medicines Agency, Amsterdam, the Netherlands Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Münster, Münster, Germany Strategic Projects Unit, Vall d 'Hebron Research Institute (VHIR), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK Universidad Autónoma de Barcelona, Barcelona, Spain 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, F-94010, Creteil, France University Medical Center Hamburg-Eppendorf, Institute of Neuroimmunology and Multiple Sclerosis (INIMS), Center for Molecular Neurobiology, Hamburg, Germany VeraSci, Durham, NC, USA Vita-Salute San Raffaele University, Milan, Italy West Tallinn Central Hospital, Tallinn, Estonia |
Issue Date: | Mar-2022 | Date: | 2021-12-15 | Publication information: | Molecular Psychiatry 2022; 27(3): 1286-1299 | 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. | URI: | https://ahro.austin.org.au/austinjspui/handle/1/30231 | DOI: | 10.1038/s41380-021-01381-x | ORCID: | http://orcid.org/0000-0001-6795-0391 http://orcid.org/0000-0003-0539-2376 http://orcid.org/0000-0002-2666-859X http://orcid.org/0000-0002-6990-939X http://orcid.org/0000-0001-5518-6138 http://orcid.org/0000-0002-2316-7220 http://orcid.org/0000-0002-6702-781X http://orcid.org/0000-0001-5473-3697 http://orcid.org/0000-0001-8260-7997 http://orcid.org/0000-0001-7867-1160 http://orcid.org/0000-0001-5693-8936 http://orcid.org/0000-0002-1286-1401 http://orcid.org/0000-0003-2291-6952 http://orcid.org/0000-0003-4949-856X http://orcid.org/0000-0002-6326-8333 http://orcid.org/0000-0001-5188-4799 http://orcid.org/0000-0002-4051-997X http://orcid.org/0000-0001-9594-0246 http://orcid.org/0000-0001-5332-3549 http://orcid.org/0000-0003-1622-0350 http://orcid.org/0000-0002-9132-5091 http://orcid.org/0000-0001-6548-426X |
Journal: | Molecular Psychiatry | PubMed URL: | 34907394 | PubMed URL: | https://pubmed.ncbi.nlm.nih.gov/34907394/ | Type: | Journal Article |
| Appears in Collections: | Journal articles |
Show full item record
Items in AHRO are protected by copyright, with all rights reserved, unless otherwise indicated.