A stratified treatment algorithm in psychiatry: a program on stratified pharmacogenomics in severe mental illness (Psych-STRATA): concept, objectives and methodologies of a multidisciplinary project funded by Horizon Europe.

Autor:	Baune BT; Department of Psychiatry, University of Muenster, Muenster, Germany. Bernhard.Baune@uni-muenster.de.; Department of Psychiatry, University of Melbourne, Melbourne, Australia. Bernhard.Baune@uni-muenster.de.; Department of Psychiatry, The Florey Institute of Neuroscience and Mental Health, Melbourne, Australia. Bernhard.Baune@uni-muenster.de., Fromme SE; Department of Psychiatry, University of Muenster, Muenster, Germany., Aberg M; Department of Medical Science, Clinical Chemistry and SciLifeLab Affinity Proteomics, Uppsala University, Uppsala, Sweden., Adli M; Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité Universitätsmedizin Berlin, Berlin, Germany.; Fliedner Klinik Berlin, Berlin, Germany., Afantitis A; Department of Chemoinformatics, NovaMechanics MIKE, Piraeus, Greece., Akkouh I; Department of Medical Genetics, Oslo University Hospital, Oslo, Norway.; Centre for Precision Psychiatry, Division of Mental Health and Addiction, University of Oslo, and Oslo University Hospital Oslo, Oslo, Norway., Andreassen OA; Centre for Precision Psychiatry, Division of Mental Health and Addiction, University of Oslo, and Oslo University Hospital Oslo, Oslo, Norway., Angulo C; Global Alliance of Mental Illness Advocacy Networks Europe, Brussels, Belgium., Barlati S; Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.; Department of Mental Health and Addiction Services, ASST Spedali Civili of Brescia, Brescia, Italy., Brasso C; Department of Neuroscience, University of Turin, Turin, Italy., Bucci P; Department of Mental and Physical Health and Preventive Medicine, University of Campania Luigi Vanvitelli, Naples, Italy., Budde M; Institute of Psychiatric Phenomics and Genomics (IPPG), University Hospital Munich, Munich, Germany., Buspavanich P; Department of Psychiatry, Psychosomatic and Psychotherapy, Brandenburg Medical School, Neuruppin, Germany.; Gender in Medicine, Institute of Sexology and Sexual Medicine, Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Berlin, Germany., Cavone V; Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, IiSGM, CIBERSAM, ISCIII, School of Medicine, Universidad Complutense, Madrid, Spain., Demyttenaere K; KU Leuven and University Psychiatric Center KU Leuven, Leuven, Belgium., Diaz-Caneja CM; Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, IiSGM, CIBERSAM, ISCIII, School of Medicine, Universidad Complutense, Madrid, Spain., Dierssen M; Universitat Pompeu Fabra, Barcelona, Spain.; Centre for Genomic Regulation, The Barcelona Institute of Science and Technology, Barcelona, Spain.; Hospital del Mar Research Institute, Barcelona, Spain., Djurovic S; Department of Medical Genetics, Oslo University Hospital, Oslo, Norway.; Centre for Precision Psychiatry, Division of Mental Health and Addiction, University of Oslo, and Oslo University Hospital Oslo, Oslo, Norway., Driessen M; Department of Psychiatry and Psychotherapy, Ev. Hospital Bethel, Bielefeld University, Bielefeld, Germany., Ebner-Priemer UW; Mental mHealth Lab, Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.; Department of Psychiatry and Psychotherapy, Medical Faculty Mannheim, Central Institute of Mental Health, University of Heidelberg, Mannheim, Germany., Engelmann J; Department of Psychiatry and Psychotherapy, University Medical Center, University of Mainz, Mainz, Germany., Englisch S; Department of Psychiatry and Psychotherapy, University Medical Center, University of Mainz, Mainz, Germany., Fabbri C; Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy., Fossati P; Department of Psychiatry, Paris Brain Institute - Institut du Cerveau (ICM), UMR 7225/UMRS 1127, Sorbonne University/CNRS/INSERM, DMU Neurosciences, Pitié-Salpétrièren, APHP, Paris, France., Fröhlich H; Department of Bioinformatics, Fraunhofer Institute for Algorithms and Scientific Computing, Sankt Augustin, Germany.; Bonn-Aachen International Center for IT (B-It), University of Bonn, Bonn, Germany., Gasser S; Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology, Division of Psychiatry I, Medical University of Innsbruck, Innsbruck, Austria., Gottlieb N; Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, IiSGM, CIBERSAM, ISCIII, School of Medicine, Universidad Complutense, Madrid, Spain., Heirman E; KU Leuven and University Psychiatric Center KU Leuven, Leuven, Belgium., Hofer A; Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology, Division of Psychiatry I, Medical University of Innsbruck, Innsbruck, Austria., Howes O; Department of Psychosis Studies, King's College London, London, UK., Ilzarbe L; Bipolar and Depressive Disorders Unit, Institute of Neurosciences, Hospital Clinic de Barcelona, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain., Jeung-Maarse H; Department of Psychiatry and Psychotherapy, Ev. Hospital Bethel, Bielefeld University, Bielefeld, Germany., Kessing LV; Psychiatric Center Copenhagen, Copenhagen, and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark., Kockler TD; Mental mHealth Lab, Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany., Landén M; Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden., Levi L; Drora and Pinchas Zachai Division of Psychiatry, Sheba Medical Center, Ramat-Gan, Israel.; Department of Psychiatry, Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel., Lieb K; Department of Psychiatry and Psychotherapy, University Medical Center, University of Mainz, Mainz, Germany., Lorenzon N; Centre for Genomic Regulation, The Barcelona Institute of Science and Technology, Barcelona, Spain., Luykx J; Department of Psychiatry, Amsterdam University Medical Center, Amsterdam, The Netherlands.; GGZ inGeest Mental Health Care, Amsterdam, The Netherlands.; Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University Medical Center, Maastricht, The Netherlands., Manchia M; Unit of Psychiatry, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.; Unit of Clinical Psychiatry, University Hospital Agency of Cagliari, Cagliari, Italy.; Department of Pharmacology, Dalhousie University, Halifax, Canada., Martinez de Lagran M; Centre for Genomic Regulation, The Barcelona Institute of Science and Technology, Barcelona, Spain., Minelli A; Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.; Genetics Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy., Moreno C; Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, IiSGM, CIBERSAM, ISCIII, School of Medicine, Universidad Complutense, Madrid, Spain., Mucci A; Department of Mental and Physical Health and Preventive Medicine, University of Campania Luigi Vanvitelli, Naples, Italy., Müller-Myhsok B; Statistical Genetics, Max Planck Institute of Psychiatry, Munich, Germany., Nilsson P; Division of Affinity Proteomics, Department of Protein Science, SciLifeLab, KTH Royal Institute of Technology, Stockholm, Sweden., Okhuijsen-Pfeifer C; Department of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands., Papavasileiou KD; Department of Chemoinformatics, NovaMechanics MIKE, Piraeus, Greece., Papiol S; Institute of Psychiatric Phenomics and Genomics (IPPG), University Hospital Munich, Munich, Germany., Pardinas AF; Centre for Neuropsychiatric Genetics and Genomics, Cardiff University, Cardiff, UK., Paribello P; Unit of Psychiatry, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.; Unit of Clinical Psychiatry, University Hospital Agency of Cagliari, Cagliari, Italy., Pisanu C; Department of Biomedical Sciences, Section of Neuroscience and Clinical Pharmacology, University of Cagliari, Cagliari, Italy., Potier MC; Institut du Cerveau - Paris Brain Institute - ICM, Inserm, CNRS, APHP, Hôpital de La Pitié Salpêtrière, Sorbonne Université, Paris, France., Reif A; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt am Main - Goethe University, Frankfurt am Main, Germany., Ricken R; Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité Universitätsmedizin Berlin, Berlin, Germany., Ripke S; Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité Universitätsmedizin Berlin, Berlin, Germany., Rocca P; Department of Neuroscience, University of Turin, Turin, Italy., Scherrer D; University Clinic of Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland., Schiweck C; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt am Main - Goethe University, Frankfurt am Main, Germany., Schubert KO; Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.; Division of Mental Health, Northern Adelaide Local Health Network, SA Health, Adelaide, Australia.; Headspace Adelaide Early Psychosis, Sonder, Adelaide, Australia., Schulze TG; Institute of Psychiatric Phenomics and Genomics (IPPG), University Hospital Munich, Munich, Germany.; World Psychiatric Association, Geneva University Psychiatric Hospital, Geneva, Suisse., Serretti A; Department of Medicine and Surgery, Kore University of Enna, Enna, Italy., Squassina A; Department of Biomedical Sciences, Section of Neuroscience and Clinical Pharmacology, University of Cagliari, Cagliari, Italy., Stephan C; Kairos GmbH, Bochum, Germany., Tsoumanis A; Department of Chemoinformatics, NovaMechanics MIKE, Piraeus, Greece., Van der Eycken E; Global Alliance of Mental Illness Advocacy Networks Europe, Brussels, Belgium., Vieta E; Department of Psychiatry and Psychology, Institute of Neuroscience (UBNeuro), Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Spain., Vita A; Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.; Department of Mental Health and Addiction Services, ASST Spedali Civili of Brescia, Brescia, Italy., Walters JTR; Centre for Neuropsychiatric Genetics and Genomics, Cardiff University, Cardiff, UK., Weichert D; Department of Psychiatry and Psychotherapy, University Medical Center, University of Mainz, Mainz, Germany., Weiser M; Drora and Pinchas Zachai Division of Psychiatry, Sheba Medical Center, Ramat-Gan, Israel.; Department of Psychiatry, Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel., Willcocks IR; Centre for Neuropsychiatric Genetics and Genomics, Cardiff University, Cardiff, UK., Winter-van Rossum I; Department of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands., Young AH; Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, IiSGM, CIBERSAM, ISCIII, School of Medicine, Universidad Complutense, Madrid, Spain., Ziller MJ; Department of Psychiatry, University of Muenster, Muenster, Germany.
Jazyk:	angličtina
Zdroj:	European archives of psychiatry and clinical neuroscience [Eur Arch Psychiatry Clin Neurosci] 2024 Dec 27. Date of Electronic Publication: 2024 Dec 27.
DOI:	10.1007/s00406-024-01944-3
Abstrakt:	Schizophrenia (SCZ), bipolar (BD) and major depression disorder (MDD) are severe psychiatric disorders that are challenging to treat, often leading to treatment resistance (TR). It is crucial to develop effective methods to identify and treat patients at risk of TR at an early stage in a personalized manner, considering their biological basis, their clinical and psychosocial characteristics. Effective translation of theoretical knowledge into clinical practice is essential for achieving this goal. The Psych-STRATA consortium addresses this research gap through a seven-step approach. First, transdiagnostic biosignatures of SCZ, BD and MDD are identified by GWAS and multi-modal omics signatures associated with treatment outcome and TR (steps 1 and 2). In a next step (step 3), a randomized controlled intervention study is conducted to test the efficacy and safety of an early intensified pharmacological treatment. Following this RCT, a combined clinical and omics-based algorithm will be developed to estimate the risk for TR. This algorithm-based tool will be designed for early detection and management of TR (step 4). This algorithm will then be implemented into a framework of shared treatment decision-making with a novel mental health board (step 5). The final focus of the project is based on patient empowerment, dissemination and education (step 6) as well as the development of a software for fast, effective and individualized treatment decisions (step 7). The project has the potential to change the current trial and error treatment approach towards an evidence-based individualized treatment setting that takes TR risk into account at an early stage. Competing Interests: Declarations. Conflict of interest: BTB received honoraria from Angelini, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Meyers Squibb, Janssen, LivaNova, Lundbeck, Medscape, Neurotorium, Novartis, Otsuka, Pfizer, Recordati, Roche, Rovi, Sanofi, Servier, and Teva. AS is, or has been a consultant to, or has received honoraria or grants unrelated to the present work from Abbott, Abbvie, Angelini, Astra Zeneca, Clinical Data, Boehringer, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Innovapharma, Italfarmaco, Janssen, Lundbeck, Naurex, Pfizer, Polifarma, Sanofi, Servier, and Taliaz. AM received advisory board or consultant fees from Angelini, Pierre Fabre, Rovi Pharma, and Boehringer Ingelheim outside the submitted work. OH has received investigator-initiated research funding from and/or participated in advisory/speaker meetings organized by Alkermes, Angellini, Autifony, Biogen, Boehringer Ingelheim, Delix, Eli Lilly, Elysium, Heptares, Global Medical Education, Invicro, Janssen, Karuna, Lundbeck, Merck, Neumora, Neurocrine, Ontrack/Pangea, Otsuka, Sunovion, Teva, Recordati, Roche, Rovi, and Viatris/Mylan. He was previously a part-time employee of Lundbeck A/v. HF received grants from Abbvie, UCB, and Neuway Pharma. PR received honoraria as a consultant for lectures from Angelini, Janssen, Lundbeck, and Otsuka. Furthermore, PR is on Angelini’s advisory board. OAA is a consultant to Cortechs.ai and Precision Health.ai, and has received speaker’s honoraria from Janssen, Lundbeck, Sunovion, and Otsuka. LVK has been a consultant for Lundbeck and Teva within the preceding three years. AH has received investigator-initiated research funding from and/or participated in advisory/speaker meetings organized by Boehringer Ingelheim, Gedeon Richter, Janssen, Lundbeck, Newron Pharmaceuticals, and Rovi. AV received advisory board, lecture, or consulting fees outside the present work from Angelini, Innova Pharma-Recordati, Janssen Pharmaceuticals, Lundbeck, Otsuka, and Pfizer. CF was a speaker for Janssen. MM received honoraria from Angelini, Lundbeck, Johnson & Johnson, and Fidia Farmaceutici. UE-P reports consultancy for Boehringer Ingelheim and speaker honorarium from Angelini Pharma. AR has received honoraria for lectures and/or advisory boards from Janssen, Boehringer Ingelheim, COMPASS, SAGE/Biogen, LivaNova, Medice, Shire/Takeda, MSD, and cyclerion. In addition, he has received research grants from Medice and Janssen. KDP and AA are employed by NovaMechanics, a cheminformatics company. JTRW was supported by a collaborative research grant from Takeda Pharmaceuticals Ltd. for a project unrelated to work presented here. AFP and JTRW also received grants from Akrivia Health for a project unrelated to this research. EV has received grants and served as a consultant, advisor, or CME speaker for AB-Biotics, AbbVie, Adamed, Alcediag, Angelini, Biogen, Beckley-Psytech, Biohaven, Boehringer Ingelheim, Celon Pharma, Compass, Dainippon Sumitomo Pharma, Ethypharm, Ferrer, Gedeon Richter, GH Research, Glaxo-Smith Kline, HMNC, Idorsia, Johnson & Johnson, Lundbeck, Luye Pharma, Medincell, Merck, Newron, Novartis, Orion Corporation, Organon, Otsuka, Roche, Rovi, Sage, Sanofi-Aventis, Sunovion, Takeda, Teva, and Viatris outside the submitted work. LI has received CME-related honoraria and/or travel support from Angelini, Casen Recordati, Exeltis, Janssen-Cilag, Lundbeck, Rovi, Rubió, and Takeda outside the submitted work. PF served as a consultant or CME speaker for Idorsia, Lundbeck, and Janssen. AR has received honoraria from and/or serves on advisory boards for Medice, Shire/Takeda, SAGE/Biogen, Janssen, Boehringer Ingelheim, and cyclerion. MW serves as a consultant, speaker, and received funding for research from Janssen, Alkermes, Lundbeck, Teva, Newron, Dexcel, MSD, and Minerva. SB received advisory board, lecture, or consulting fees outside the present work from Angelini, Janssen Pharmaceuticals, Lundbeck, and Otsuka. ML has received lecture honoraria from Lundbeck pharmaceuticals. CB, IW, JL, SEF, KL, JE, DW, CS, COP, PN, PB, M-CP, MA, TDK, MML, and SE declare no conflict of interest. RR received an unrestricted research grant and speaker honoraria from Aristo Pharma. MA received research grants from Berlin University Alliance, Volkswagen Stiftung, Stiftung für Analytische Psychiatrie, and Gilead as well as speaker or consultation honoraria or travel reimbursements from Johnson & Johnson, Aristo Pharma, Gilead, and Neuraxpharm. BMM has a secondary appointment as head of precision psychiatry with HMNC Brain Health. CM has received honoraria as a consultant and/or advisor for lectures from Angelini, Compass, Esteve, Exeltis Janssen, Lundbeck, Neuraxpharm, Nuvelution, Otsuka, Pfizer, Servier, and Sunovion outside the submitted work. CMDC has received honoraria and/or travel support from Angelini, Janssen, and Viatris not related to the submitted work. AHY received paid lectures and advisory boards from Flow Neuroscience, Novartis, Roche, Janssen, Takeda, Noemapharma, Compass, Astrazenaca, Boehringer Ingelheim, Eli Lilly, LivaNova, Lundbeck, Sunovion, Servier, Livanova, Janssen, Allegan, Bionomics, Sumitomo Dainippon Pharma, Sage, and Neurocentrx. KOS received honoraria from Janssen and Lundbeck as well as research funding from Janssen, Lundbeck, and Gilead. Ethical approval: The RCT in step 3 has been planned in accordance with the Helsinki Declaration and will be conducted in this way. In addition, ethical approvals have either already been granted or are pending but have been applied for: Australia: not yet approved. Austria: SZ: 2023–506602-39–00, BD: 2023–506605-19–00, MDD: 2023–506617-21–00. All approved by the ethical committee of the Medical University of Innsbruck. Germany: SZ: 2023–506602-39–00 approved by Ethik-Kommission des Landes Berlin, BD: 2023–506605-19–00 approved by Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Universität Münster, MDD: 2023–506617-21–00 approved by Ethik-Kommission der Ärztekammer Nordrhein. Greece: SZ: 2023–506602-39–00, BD: 2023–506605-19–00, MDD: 2023–506617-21–00 Yet to be submitted; site was added later. Israel: merged protocol 0293–23-SMC, approved by the ethical committee of The Chaim Sheba Medical Center. Italy: SZ: 2023–506602-3900, BD: 2023–506605-19–00, MDD: 2023–506617-21–00. All approved by Comitato Etico Territoriale (CET) delle Marche. Poland: SZ: 2023–506602-3900, BD: 2023–506605-19–00, MDD: 2023–506617-21–00 Yet to be submitted; site was added later. Spain: SZ: 2023–506602-39–00, BD: 2023–506605-19–00, MDD: 2023–506617-21–00. All approved by CEIm del Hospital Clínic de Barcelona. United Kingdom: SZ: 2023–506602-39–00 & 23/EM/0266 approved by East Midlands—Nottingham 2 Research Ethics Committee, BD: 2023–506605-19–00 (not yet approved), MDD: 2023–506617-21–00 (not yet approved). (© 2024. The Author(s).)
Databáze:	MEDLINE
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