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A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials.
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.
Afiliação
  • Sforzini L; King's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK. luca.sforzini@kcl.ac.uk.
  • Worrell C; King's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK.
  • Kose M; King's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK.
  • Anderson IM; 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 and Manchester Academic Health Sciences Centre, Manchester, UK.
  • Aouizerate B; Department of General and Academic Psychiatry, Centre Hospitalier Charles Perrens, Laboratory of Nutrition and Integrative Neurobiology (UMR INRAE 1286), University of Bordeaux, Bordeaux, France.
  • Arolt V; Department of Psychiatry and Psychotherapy, University of Münster, Münster, Germany.
  • Bauer M; Otto Creutzfeldt Center for Cognitive and Behavioral Neuroscience, University of Münster, Münster, Germany.
  • Baune BT; Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Medical Faculty, Technische Universität Dresden, Dresden, Germany.
  • Blier P; Department of Psychiatry and Psychotherapy, University of Münster, Münster, Germany.
  • Cleare AJ; Department of Psychiatry, Melbourne Medical School and The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Parkville, VIC, Australia.
  • Cowen PJ; Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.
  • Dinan TG; Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada.
  • Fagiolini A; Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, ON, Canada.
  • Ferrier IN; King's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK.
  • Hegerl U; National Institute for Health Research Mental Health Biomedical Research Centre, South London and Maudsley NHS Foundation Trust and King's College London, London, UK.
  • Krystal AD; Medical Sciences Division, Department of Psychiatry, University of Oxford, Oxford, UK.
  • Leboyer M; APC Microbiome Ireland, Cork, Ireland; Department of Psychiatry and Neurobehavioral Sciences, University College Cork, Cork, Ireland.
  • McAllister-Williams RH; Department of Molecular Medicine, Division of Psychiatry, University of Siena, Siena, Italy.
  • McIntyre RS; Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
  • Meyer-Lindenberg A; Depression Research Center of the German Depression Foundation and Department of Psychiatry, Psychosomatics and Psychotherapy, Goethe University, Frankfurt, Germany.
  • Miller AH; Department of Psychiatry, University of California, San Francisco, San Francisco, CA, USA.
  • Nemeroff CB; Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.
  • Normann C; 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.
  • Nutt D; Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
  • Pallanti S; Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, UK.
  • Pani L; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.
  • Penninx BWJH; Department of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada.
  • Schatzberg AF; Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.
  • Shelton RC; Brain and Cognition Discovery Foundation, Toronto, ON, Canada.
  • Yatham LN; Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Square J5, 68159, Mannheim, Germany.
  • Young AH; Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, 30322, USA.
  • Zahn R; Department of Psychiatry, University of Texas at Austin, Dell Medical School, Austin, TX, USA.
  • Aislaitner G; Department for Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstrasse 5, 79104, Freiburg, Germany.
  • Butlen-Ducuing F; Centre for Neuropsychopharmacology, Division of Psychiatry, Imperial College, London, London, UK.
  • Fletcher C; Istituto di Neuroscience, University of Florence, Italy; Albert Einstein College of Medicine, New York, USA.
  • Haberkamp M; Department of Psychiatry and Behavioral Sciences, Psychiatry University of Miami, Miami, FL, USA.
  • Laughren T; Department of Biomedical, Metabolic & Neural Sciences, University of Modena, Modena, Italy.
  • Mäntylä FL; VeraSci, Durham, NC, USA.
  • Schruers K; Department of Psychiatry, Amsterdam UMC, Vrije Universiteit and GGZinGeest, Amsterdam, the Netherlands.
  • Thomson A; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.
  • Arteaga-Henríquez G; Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USA.
  • Benedetti F; Department of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.
  • Cash-Gibson L; King's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK.
  • Chae WR; National Institute for Health Research Mental Health Biomedical Research Centre, South London and Maudsley NHS Foundation Trust and King's College London, London, UK.
  • De Smedt H; King's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK.
  • Gold SM; National Institute for Health Research Mental Health Biomedical Research Centre, South London and Maudsley NHS Foundation Trust and King's College London, London, UK.
  • Hoogendijk WJG; Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Bonn, Germany.
  • Mondragón VJ; Office of Therapies for Neurological and Psychiatric disorders, Human Medicines Division, European Medicines Agency, Amsterdam, the Netherlands.
  • Maron E; Biostatistics, GlaxoSmithKline, London, UK.
  • Martynowicz J; Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Bonn, Germany.
Mol Psychiatry ; 27(3): 1286-1299, 2022 03.
Article em En | MEDLINE | ID: mdl-34907394
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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Transtorno Depressivo Maior / Transtorno Depressivo Resistente a Tratamento Tipo de estudo: Guideline Limite: Humans Idioma: En Revista: Mol Psychiatry Assunto da revista: BIOLOGIA MOLECULAR / PSIQUIATRIA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Reino Unido
Texto completo
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Transtorno Depressivo Maior / Transtorno Depressivo Resistente a Tratamento Tipo de estudo: Guideline Limite: Humans Idioma: En Revista: Mol Psychiatry Assunto da revista: BIOLOGIA MOLECULAR / PSIQUIATRIA Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Reino Unido