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Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/30231
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dc.contributor.authorSforzini, Luca-
dc.contributor.authorWorrell, Courtney-
dc.contributor.authorKose, Melisa-
dc.contributor.authorAnderson, Ian M-
dc.contributor.authorAouizerate, Bruno-
dc.contributor.authorArolt, Volker-
dc.contributor.authorBauer, Michael-
dc.contributor.authorBaune, Bernhard T-
dc.contributor.authorBlier, Pierre-
dc.contributor.authorCleare, Anthony J-
dc.contributor.authorCowen, Philip J-
dc.contributor.authorDinan, Timothy G-
dc.contributor.authorFagiolini, Andrea-
dc.contributor.authorFerrier, I Nicol-
dc.contributor.authorHegerl, Ulrich-
dc.contributor.authorKrystal, Andrew D-
dc.contributor.authorLeboyer, Marion-
dc.contributor.authorMcAllister-Williams, R Hamish-
dc.contributor.authorMcIntyre, Roger S-
dc.contributor.authorMeyer-Lindenberg, Andreas-
dc.contributor.authorMiller, Andrew H-
dc.contributor.authorNemeroff, Charles B-
dc.contributor.authorNormann, Claus-
dc.contributor.authorNutt, David-
dc.contributor.authorPallanti, Stefano-
dc.contributor.authorPani, Luca-
dc.contributor.authorPenninx, Brenda W J H-
dc.contributor.authorSchatzberg, Alan F-
dc.contributor.authorShelton, Richard C-
dc.contributor.authorYatham, Lakshmi N-
dc.contributor.authorYoung, Allan H-
dc.contributor.authorZahn, Roland-
dc.contributor.authorAislaitner, Georgios-
dc.contributor.authorButlen-Ducuing, Florence-
dc.contributor.authorFletcher, Christine-
dc.contributor.authorHaberkamp, Marion-
dc.contributor.authorLaughren, Thomas-
dc.contributor.authorMäntylä, Fanni-Laura-
dc.contributor.authorSchruers, Koen-
dc.contributor.authorThomson, Andrew-
dc.contributor.authorArteaga-Henríquez, Gara-
dc.contributor.authorBenedetti, Francesco-
dc.contributor.authorCash-Gibson, Lucinda-
dc.contributor.authorChae, Woo Ri-
dc.contributor.authorDe Smedt, Heidi-
dc.contributor.authorGold, Stefan M-
dc.contributor.authorHoogendijk, Witte J G-
dc.contributor.authorMondragón, Valeria Jordán-
dc.contributor.authorMaron, Eduard-
dc.contributor.authorMartynowicz, Jadwiga-
dc.contributor.authorMelloni, Elisa-
dc.contributor.authorOtte, Christian-
dc.contributor.authorPerez-Fuentes, Gabriela-
dc.contributor.authorPoletti, Sara-
dc.contributor.authorSchmidt, Mark E-
dc.contributor.authorvan de Ketterij, Edwin-
dc.contributor.authorWoo, Katherine-
dc.contributor.authorFlossbach, Yanina-
dc.contributor.authorRamos-Quiroga, J Antoni-
dc.contributor.authorSavitz, Adam J-
dc.contributor.authorPariante, Carmine M-
dc.date2021-12-15-
dc.date.accessioned2022-06-23T00:29:43Z-
dc.date.available2022-06-23T00:29:43Z-
dc.date.issued2022-03-
dc.identifier.citationMolecular Psychiatry 2022; 27(3): 1286-1299en
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/30231-
dc.description.abstractCriteria 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.en
dc.language.isoeng-
dc.titleA Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials.en
dc.typeJournal Articleen
dc.identifier.journaltitleMolecular Psychiatryen
dc.identifier.affiliationThe Florey Institute of Neuroscience and Mental Healthen
dc.identifier.affiliationAlbert Einstein College of Medicine, New York, USAen
dc.identifier.affiliationAPC Microbiome Ireland, Cork, Irelanden
dc.identifier.affiliationBiomedical Network Research Centre on Mental Health (CIBERSAM), Barcelona, Catalonia, Spainen
dc.identifier.affiliationBiomedical Network Research Centre on Mental Health (CIBERSAM), Madrid, Spainen
dc.identifier.affiliationBiostatistics, GlaxoSmithKline, London, UKen
dc.identifier.affiliationBrain and Cognition Discovery Foundation, Toronto, ON, Canadaen
dc.identifier.affiliationCentre for Neuropsychopharmacology, Division of Psychiatry, Imperial College, London, London, UKen
dc.identifier.affiliationCharité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Berlin, Germanyen
dc.identifier.affiliationCharité - Universitätsmedizin Berlin, Department of Psychosomatic Medicine, Campus Benjamin Franklin, Berlin, Germanyen
dc.identifier.affiliationCumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, UKen
dc.identifier.affiliationData, Analytics and Methodology Taskforce, European Medicines Agency, Amsterdam, the Netherlandsen
dc.identifier.affiliationDepartment for Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstrasse 5, 79104, Freiburg, Germanyen
dc.identifier.affiliationDepartment of Biomedical, Metabolic & Neural Sciences, University of Modena, Modena, Italyen
dc.identifier.affiliationDepartment of Cellular and Molecular Medicine, University of Ottawa, Ottawa, ON, Canadaen
dc.identifier.affiliationDepartment of General and Academic Psychiatry, Centre Hospitalier Charles Perrens, Laboratory of Nutrition and Integrative Neurobiology (UMR INRAE 1286), University of Bordeaux, Bordeaux, Franceen
dc.identifier.affiliationDepartment of Global Regulatory Affairs, Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USAen
dc.identifier.affiliationDepartment of Molecular Medicine, Division of Psychiatry, University of Siena, Siena, Italyen
dc.identifier.affiliationDepartment of Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USAen
dc.identifier.affiliationDepartment of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canadaen
dc.identifier.affiliationDepartment of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USAen
dc.identifier.affiliationDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, 30322, USAen
dc.identifier.affiliationDepartment of Psychiatry and Behavioral Sciences, Psychiatry University of Miami, Miami, FL, USAen
dc.identifier.affiliationDepartment of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USAen
dc.identifier.affiliationDepartment of Psychiatry and Forensic Medicine, Universitat Autònoma de Barcelona, Barcelona, Catalonia, Spainen
dc.identifier.affiliationDepartment of Psychiatry and Neurobehavioral Sciences, University College Cork, Cork, Irelanden
dc.identifier.affiliationDepartment of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlandsen
dc.identifier.affiliationDepartment of Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Square J5, 68159, Mannheim, Germanyen
dc.identifier.affiliationDepartment of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Medical Faculty, Technische Universität Dresden, Dresden, Germanyen
dc.identifier.affiliationDepartment of Psychiatry and Psychotherapy, University of Münster, Münster, Germanyen
dc.identifier.affiliationDepartment of Psychiatry, Amsterdam UMC, Vrije Universiteit and GGZinGeest, Amsterdam, the Netherlandsen
dc.identifier.affiliationDepartment of Psychiatry, Erasmus University Medical Centre, Rotterdam, the Netherlandsen
dc.identifier.affiliationDepartment of Psychiatry, Hospital Universitari Vall d'Hebron (HUVH), Barcelona, Catalonia, Spainen
dc.identifier.affiliationDepartment of Psychiatry, Melbourne Medical School, The University of Melbourne, Parkville, VIC, Australiaen
dc.identifier.affiliationDepartment of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USAen
dc.identifier.affiliationDepartment of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canadaen
dc.identifier.affiliationDepartment of Psychiatry, University of California, San Francisco, San Francisco, CA, USAen
dc.identifier.affiliationDepartment of Psychiatry, University of Ottawa, Ottawa, ON, Canadaen
dc.identifier.affiliationDepartment of Psychiatry, University of Tartu, Tartu, Estoniaen
dc.identifier.affiliationDepartment of Psychiatry, University of Texas at Austin, Dell Medical School, Austin, TX, USAen
dc.identifier.affiliationDepartment of Psychiatry, University of Toronto, Toronto, ON, Canadaen
dc.identifier.affiliationDepression Research Center of the German Depression Foundation and Department of Psychiatry, Psychosomatics and Psychotherapy, Goethe University, Frankfurt, Germanyen
dc.identifier.affiliationDivision of Neuroscience, Psychiatry and Clinical Psychobiology, IRCCS Scientific Institute Ospedale San Raffaele, Milan, Italyen
dc.identifier.affiliationDocumental Ltd, Tallin, Estoniaen
dc.identifier.affiliationEuropean Infrastructure for Translational Medicine (EATRIS), Amsterdam, Netherlandsen
dc.identifier.affiliationExperimental Medicine, Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgiumen
dc.identifier.affiliationFaculty of Medicine, Department of Medicine, Centre for Neuropsychopharmacology, Division of Brain Sciences, Imperial College London, London, UKen
dc.identifier.affiliationFaculty of Psychology, Center for Experimental and Learning Psychology, University of Leuven, Leuven, Belgiumen
dc.identifier.affiliationFederal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Bonn, Germanyen
dc.identifier.affiliationGAMIAN-Europe (Global Alliance of Mental Illness Advocacy Networks-Europe), Brussels, Belgiumen
dc.identifier.affiliationGroup of Psychiatry, Mental Health and Addictions, Vall d'Hebron Research Institute (VHIR), Barcelona, Catalonia, Spainen
dc.identifier.affiliationIstituto di Neuroscience, University of Florence, Italyen
dc.identifier.affiliationJanssen Research & Development, Beerse, Belgiumen
dc.identifier.affiliationKing's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UKen
dc.identifier.affiliationLaughren Psychopharm Consulting, LLC, Rockville, MD, USAen
dc.identifier.affiliationManchester Academic Health Sciences Centre, Manchester, UKen
dc.identifier.affiliationMaudsley NHS Foundation Trust and King's College London, London, UKen
dc.identifier.affiliationMedical Director Neuroscience for Region Europe at Novartis Pharma, Basel, Switzerlanden
dc.identifier.affiliationMedical Sciences Division, Department of Psychiatry, University of Oxford, Oxford, UKen
dc.identifier.affiliationMood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canadaen
dc.identifier.affiliationMood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canadaen
dc.identifier.affiliationNational Institute for Health Research Mental Health Biomedical Research Centre, South London, UKen
dc.identifier.affiliationNeuroscience 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, UKen
dc.identifier.affiliationNeuroscience, Global Drug Development, Novartis Pharma AG, Basel, Switzerlanden
dc.identifier.affiliationOffice of Therapies for Neurological and Psychiatric disorders, Human Medicines Division, European Medicines Agency, Amsterdam, the Netherlandsen
dc.identifier.affiliationOtto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Münster, Münster, Germanyen
dc.identifier.affiliationStrategic Projects Unit, Vall d 'Hebron Research Institute (VHIR), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spainen
dc.identifier.affiliationTranslational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UKen
dc.identifier.affiliationUniversidad Autónoma de Barcelona, Barcelona, Spainen
dc.identifier.affiliationUniversité 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, Franceen
dc.identifier.affiliationUniversity Medical Center Hamburg-Eppendorf, Institute of Neuroimmunology and Multiple Sclerosis (INIMS), Center for Molecular Neurobiology, Hamburg, Germanyen
dc.identifier.affiliationVeraSci, Durham, NC, USAen
dc.identifier.affiliationVita-Salute San Raffaele University, Milan, Italyen
dc.identifier.affiliationWest Tallinn Central Hospital, Tallinn, Estoniaen
dc.identifier.pubmedurihttps://pubmed.ncbi.nlm.nih.gov/34907394/en
dc.identifier.doi10.1038/s41380-021-01381-xen
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