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Article History

Received: 29 August 2021

Revised: 11 October 2021

Accepted: 26 October 2021

First Online: 15 December 2021

Competing interests

: LS reports grant from European Commission (IMI2 853966), during the conduct of the study. CW reports grant from European Commission (IMI2 853966), during the conduct of the study. MK reports grant from European Commission (IMI2 853966), during the conduct of the study. IMA has nothing to disclose. BA reports personal fees from Lundbeck, personal fees and non-financial support from Janssen-Cilag, personal fees from Sanofi, personal fees from Eli Lilly, outside the submitted work; and has served on the advisory board of Janssen-Cilag. VA reports personal fees from Astra-Zeneca, personal fees from Gilead Sciences, personal fees from Janssen, personal fees from Lundbeck, personal fees from Neuraxpharm, personal fees from Otsuka, personal fees from Sanofi/Genzyme, personal fees from Servier, grants from European Union- Horizon 2020, grants from Medical Faculty Muenster- Interdisciplinary Center for Clinical Research, outside the submitted work; and Has served on Advisory Boards for Allergan, Astra-Zeneca, Janssen, Lundbeck, Neuraxpharm, Otsuka, Sanofi/Genzyme, Servier and Trommsdorff. MB reports grants from Deutsche Forschungsgemeinschaft (DFG), grants from European Commission, grants from Bundesministerium für Bildung und Forschung (BMBF), personal fees from Aristo, personal fees from GH Research, personal fees from Hexal, personal fees from Janssen, personal fees from Janssen-Cilag, personal fees from Neuraxpharm, personal fees from Novartis, personal fees from Sandoz, personal fees from Shire International, personal fees from Sunovion, personal fees from Takeda, outside the submitted work. BTB reports personal fees from AstraZeneca, personal fees from Lundbeck, personal fees from Pfizer, personal fees from Takeda, personal fees from Servier, personal fees from Bristol Myers Squibb, personal fees from Otsuka, personal fees from LivaNova, personal fees from Janssen-Cilag, outside the submitted work. PB reports personal fees from Allergan, personal fees from Eisai, personal fees from Janssen, personal fees from Lundbeck, personal fees from Otsuka, personal fees from Pfizer, personal fees from Pierre Fabre Médicaments, personal fees from Takeda, outside the submitted work; and Expert testimony was provided on behalf of Allergan, Bristol Myers Squibb and Otsuka. AJC reports personal fees from Lundbeck, personal fees from Janssen, personal fees from Livanova, personal fees from Allergan, personal fees from NICE, grants from Medical Research Council (UK), grants from Wellcome Trust (UK), grants from National Institute for Health Research (UK), grants from Protexin Probiotics International Ltd., outside the submitted work. PJC has a patent for Ebselen in treatment-resistant depression pending. TGD has nothing to disclose. AF reports grants and personal fees from Angelini, grants and personal fees from Apsen, grants and personal fees from Boheringer Ingelheim, grants and personal fees from Daiichi Sankyo, grants and personal fees from Doc Generici, grants and personal fees from Glaxo Smith Kline, grants and personal fees from Italfarmaco, grants and personal fees from Lundbeck, grants and personal fees from Janssen, grants and personal fees from Mylan, grants and personal fees from Neuraxpharm, grants and personal fees from Otsuka, grants and personal fees from Pfizer, grants and personal fees from Recordati, grants and personal fees from Sanofi Aventis, grants and personal fees from Sunovion, grants and personal fees from Vifor, outside the submitted work. INF has nothing to disclose. UH reports personal fees from Janssen, personal fees from Servier, personal fees from Medice, outside the submitted work. ADK reports grants and personal fees from Janssen Pharmaceuticals, grants from Axsome Pharmaceutics, grants from Reveal Biosensors, grants from The Ray and Dagmar Dolby Family Fund, grants from National Institutes of Health, personal fees from Adare, personal fees from Axsome Therapeutics, personal fees from Big Health, personal fees from Eisai, personal fees from Evecxia, personal fees from Ferring Pharmaceuticals, personal fees from Galderma, personal fees from Harmony Biosciences, personal fees from Idorsia, personal fees from Jazz Pharmaceuticals, personal fees from Millenium Pharmaceuticals, personal fees from Merck, personal fees from Neurocrine Biosciences, personal fees from Neurawell, personal fees from Pernix, personal fees from Otsuka Pharmaceuticals, personal fees from Sage, personal fees from Takeda, personal fees from Harmony, outside the submitted work. ML has nothing to disclose. RHM-W reports personal fees from Janssen-Cilag, personal fees from LivaNova, personal fees from Lundbeck, personal fees from P1 Vital Ltd, personal fees from Pfizer, personal fees from Sage Therapeutics, personal fees from Sunovian, non-financial support from MagStim, grants from AstraZeneca, personal fees from My Tomorrows, personal fees from OCM Communications s.n.c, personal fees from Syntropharma, outside the submitted work. RSM reports grants from CIHR, grants from GACD, grants from Chinese National Natural Research Foundation, personal fees from Lundbeck, personal fees from Janssen, personal fees from Purdue, personal fees from Pfizer, personal fees from Otsuka, personal fees from Allergan, personal fees from Takeda, personal fees from Neurocrine, personal fees from Sunovion, personal fees from Eisai, personal fees from Minerva, personal fees from Intra-Cellular, personal fees from Abbvie, other from AltMed, outside the submitted work. AM-L reports personal fees from Agence Nationale de la Recherche, personal fees from American Association for the Advancement of Science, personal fees from Brain Mind Institute, personal fees from Brainsway, personal fees from Catania International Summer School of Neuroscience (CISSN), personal fees from Daimler und Benz Stiftung, personal fees from Fondation FondaMental, personal fees from Janssen-Cilag GmbH, personal fees from Lundbeck A/S, personal fees from Lundbeck Int. Neuroscience Foundation, personal fees from MedinCell, personal fees from Sage Therapeutics, personal fees from Techspert.io, personal fees from Thieme Verlag, personal fees from von Behring Röntgen Stiftung, personal fees from BAG Psychiatrie Oberbayern, personal fees from Biotest AG, personal fees from Forum Werkstatt Karlsruhe, personal fees from International Society of Psychiatric Genetics, personal fees from Brentwood, personal fees from Klinik für Psychiatrie und Psychotherapie Ingolstadt, personal fees from Lundbeck SAS France, personal fees from med Update GmbH, personal fees from Merz-Stiftung, personal fees from Siemens Healthineers, outside the submitted work. AHM reports personal fees from Boehringer Ingelheim, outside the submitted work. CBN reports grants from National Institutes of Health (NIH), personal fees from ANeuroTech (division of Anima BV), personal fees from Taisho Pharmaceutical, Inc, personal fees from Takeda, personal fees from Signant Health, personal fees from Sunovion Pharmaceuticals, Inc, personal fees from Janssen Research & Development LLC, personal fees from Magstim, Inc, personal fees from Navitor Pharmaceuticals, Inc, personal fees from Intra-Cellular Therapies, Inc, personal fees and other from EMA Wellness, personal fees from Acadia Pharmaceuticals, personal fees from Axsome, personal fees from Sage, personal fees from BioXcel Therapeutics, personal fees from Silo Pharma, personal fees from XW Pharma, personal fees from Neuritek, personal fees from Engrail Therapeutics, personal fees from Brain and Behavior Research Foundation (BBRF), personal fees and other from Anxiety and Depression Association of America (ADAA), personal fees from Skyland Trail, personal fees from Signant Health, personal fees from Laureate Institute for Brain Research (LIBR), Inc, personal fees from Magnolia CNS, other from Gratitude America, other from Xhale Smart, Inc, other from Xhale, other from Seattle Genetics, other from Antares, other from BI Gen Holdings, Inc, other from Corcept Therapeutics Pharmaceuticals Company, from null, outside the submitted work; In addition, CBN has a patent Method and devices for transdermal delivery of lithium (US 6, 375, 990B1) issued, and a patent Method of assessing antidepressant drug therapy via transport inhibition of monoamine neurotransmitters by ex vivo assay (US 7, 148, 027B2) issued. CN reports personal fees from Johnson/Janssen-Cilag, outside the submitted work. DN reports personal fees from British National Formulary, personal fees from Ranvier, personal fees from Opiant, personal fees from COMPASS Pathways, personal fees from AWAKN, personal fees from Psyched Wellness, personal fees from Lundbeck, personal fees from BMS/Otsuka, personal fees from Janssen, personal fees from Takeda, grants from Wellcome Trust, MRC, other from P1vital, other from Awakn, other from Psyched Wellness, other from Equasy Enterprises, other from Alcarelle, outside the submitted work; and Expert witness related to psychotropic drugs in several legal cases. Edited/written more than 34 books, some purchased by pharmaceutical companies. SPa reports grants from R21 NIMH (R21DA042271-01), outside the submitted work. LP reports personal fees from University of Modena and Reggio Emilia, personal fees from University of Miami, personal fees from EDRA-LSWR Publishing Company, personal fees from Inpeco SA Total Lab Automation Company, personal fees from VeraSci, Durham, USA, personal fees from AbbVie USA, personal fees from Acadia USA, personal fees from BCG Switzerland, personal fees from Boehringer Ingelheim International GmbH, personal fees from Compass Pathways, personal fees from Ferrer Spain, personal fees from Gedeon-Richter, Hungary, personal fees from Johnson & Johnson USA, personal fees from NeuroCog Trials USA, personal fees from Novartis-Gene Therapies, Switzerland, personal fees from Otsuka USA, personal fees from Pfizer Global USA, personal fees from PharmaMar Spain, personal fees from Relmada USA, personal fees from Takeda USA, personal fees from Vifor Switzerland, outside the submitted work. BWJHP reports grants from Boehringer Ingelheim, grants from Janssen Research, outside the submitted work. AFS reports personal fees from Axsome, personal fees and other from Delpor, personal fees and other from NeuraWell, personal fees from ANeuroTech, personal fees from Signant, personal fees from Otsuka, personal fees from EMA Wellness, personal fees and other from Owl Insights, personal fees and other from Alto, personal fees and other from Verso, personal fees from Compass, personal fees from Janssen, personal fees from Tris, personal fees from Schwabe, personal fees from Boehringer Ingelheim, personal fees from McKinsey, other from Corcept, other from Merck, other from Seattle Genetics, other from XHale, other from Intersect, other from Epiodyne, outside the submitted work. RCS reports grants from Agency for Healthcare Research and Quality, grants and personal fees from Allergan, grants from Assurex Health, grants from Avanir Pharmaceuticals, grants and personal fees from Cerecor, Inc, personal fees from Clintara LLC, grants from Genomind, grants and personal fees from Janssen Pharmaceutica, personal fees from Medtronic, Inc., grants from Novartis, Inc., personal fees from Pfizer, Inc., grants and personal fees from Otsuka Pharmaceuticals, grants and personal fees from Acadia Pharmaceuticals, grants from Alkermes, PLC, grants and personal fees from Takeda Pharmaceuticals, grants from NeuroRx Inc., outside the submitted work. LNY reports personal fees from Alkermes, grants and personal fees from Allergan, personal fees from CANMAT, grants and personal fees from CIHR, grants and personal fees from Dainippon Sumitomo, grants and personal fees from Intracellular Therapies, grants and personal fees from Lundbeck, personal fees from Merck, personal fees from Otsuka, personal fees from Sanofi, personal fees from Sunovion, outside the submitted work. AHY reports personal fees from King’s College London, personal fees from Sumitomo Dainippon Pharma, grants from MRC (UK), grants from Wellcome Trust (UK), grants from NIHR (UK), outside the submitted work; and Principal Investigator in the Restore-Life VNS registry study funded by LivaNova. Principal Investigator on ESKETINTRD3004: “An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression.” Principal Investigator on “The Effects of Psilocybin on Cognitive Function in Healthy Participants.” Principal Investigator on “The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD)”. RZ reports personal fees from The London Depression Institute, personal fees from Lundbeck, personal fees from Janssen, personal fees from Depsee Ltd, personal fees from Scients Institute, Palo Alto, outside the submitted work; and Co-Investigator on a LivaNova Funded observational study of Vagus Nerve Stimulation for Depression. Collaborated with EMIS PLC for a study. Affiliated with the D’Or Institute of Research and Education, Rio de Janeiro. GA reports personal fees from BfArM (Federal Institute for Drugs and Medical Devices), personal fees from EMA (No money, honoraria or other kind of compensation paid for services rendered. Only travel and accommodation expenses are covered together with travel allowance from EMA), personal fees from University of Thessaly (Greece) and University of Nicosia (Cyprus) (Honoraria for lectures in Postgraduate Program) outside the submitted work. FB-D has nothing to disclose. CF reports personal fees and other from GSK, outside the submitted work. MH reports personal fees from BfArM, personal fees from EMA (No money, honoraria or other kind of compensation paid for services rendered. Only travel and accommodation expenses are covered together with travel allowance from EMA), personal fees from Forum-Institut, outside the submitted work. TL reports personal fees from Massachusetts General Hospital Clinical Trials Network and Institute, personal fees from Acadia, personal fees from Alairion, personal fees from Antares, personal fees from Aptinyx, personal fees from Arbor, personal fees from AxsomeBetterLife, personal fees from Biohaven, personal fees from Cadent, personal fees from Cereval, personal fees from Cingulate, personal fees from Corteyxme, personal fees from Eleusis, personal fees from Emerald Lake Safety, personal fees from Greenwich, personal fees from Harmony, personal fees from Janssen, personal fees from Karuna, personal fees from KemPharm, personal fees from LB Pharmaceuticals, personal fees from LevoTx, personal fees from MAPS, personal fees from Merck, personal fees from Minerva, personal fees from Neurocrine Biosciences, personal fees from Neuronetics, personal fees from Noema, personal fees from Novartis Pharma AG, personal fees from Novartis US, personal fees from Praxis Biosciences, personal fees from Promentis, personal fees from Tonix, personal fees from Vallon, personal fees from Waypoint, outside the submitted work. F-LM reports personal fees from HUS Helsinki University Hospital, non-financial support from European Patients’ Forum, outside the submitted work. KS has nothing to disclose. AT has nothing to disclose. GA-H reports grants from European Commission (IMI2 853966), during the conduct of the study; grants from European Union’s Horizon 2020 Research and Innovation Program (grant agreement no.728018), outside the submitted work. FB reports grants from European Commission (IMI2 853966), during the conduct of the study. LC-G reports grants from European Commission (IMI2 853966), during the conduct of the study. WRC reports grants from European Commission (IMI2 853966), during the conduct of the study. HDS reports non-financial support from EU-PEARL Project, during the conduct of the study; personal fees from Janssen, outside the submitted work. SMG reports grants from European Commission (IMI2 853966), during the conduct of the study; personal fees from Almirall SA, personal fees from Celgene, personal fees from Forum für Medizinische Fortbildung (FomF), personal fees from Mylan GmbH, non-financial support from GAIA Group, grants from Deutsche Forschungsgemeinschaft, grants from German Federal Ministry of Health, grants from National Multiple Sclerosis Society, outside the submitted work. WJGH reports grants from European Commission (IMI2 853966), during the conduct of the study. VJM reports non-financial support from EU-PEARL Project, during the conduct of the study; personal fees from Novartis Pharma AG, outside the submitted work. EMa reports grants from European Commission (IMI2 853966), during the conduct of the study; personal fees from Lundbeck, personal fees from Janssen-Cilag, outside the submitted work. JM reports non-financial support from EU-PEARL Project, during the conduct of the study; personal fees from Janssen, outside the submitted work. EMe reports grants from European Commission (IMI2 853966), during the conduct of the study. CO reports grants from European Commission (IMI2 853966), during the conduct of the study; personal fees from Ferring, personal fees from Janssen, personal fees from Lundbeck, personal fees from SAGE Therapeutics, personal fees from Fortbildungskolleg, personal fees from Limes Klinikgruppe, personal fees from Medical Tribune, grants from German Research Foundation (OT 209/7-3; 14-1, EXC 2049), grants from German Federal Ministry of Education and Research (KS2017-067), grants from Berlin Institute of Health (B3010350), outside the submitted work. GP-F reports grants from European Commission (IMI2 853966), during the conduct of the study. SPo reports grants from European Commission (IMI2 853966), during the conduct of the study. MES reports non-financial support from EU-PEARL Project, during the conduct of the study; personal fees from Janssen Pharmaceutica NV, other from Johnson & Johnson, other from Novartis Inc., outside the submitted work. EvdK reports grants from European Commission (IMI2 853966), during the conduct of the study. KW reports non-financial support from EU-PEARL Project, during the conduct of the study; personal fees from Janssen R&D LLC, other from Johnson & Johnson, outside the submitted work. YF reports non-financial support from EU-PEARL Project, during the conduct of the study; personal fees from Novartis Pharma AG, outside the submitted work. JAR-Q reports grants from European Commission (IMI2 853966), during the conduct of the study; personal fees and non-financial support from Eli-Lilly, personal fees and non-financial support from Janssen-Cilag, personal fees from Novartis, personal fees and non-financial support from Shire, personal fees and non-financial support from Takeda, personal fees from Bial, personal fees and non-financial support from Shionogi, personal fees from Lundbeck, personal fees from Almirall, personal fees from Braingaze, personal fees from Sincrolab, personal fees and non-financial support from Medice, personal fees and non-financial support from Rubió, personal fees from Raffo, personal fees from Actelion, personal fees from Ferrer, personal fees from Oryzon, personal fees from Roche, personal fees from Psious, outside the submitted work. AJS reports non-financial support from EU-PEARL Project, during the conduct of the study; personal fees from Johnson & Johnson, outside the submitted work (employee and own stock in the company). CMP reports grants from European Commission (IMI2 853966), during the conduct of the study. Additional funding has been provided by UK National Institute of Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Trust and King’s College London. He is also funded by a NIHR Senior Investigator Award. He has received research or consultation funding from Johnson & Johnson and Boehringer Ingelheim, as well as research funding from the Medical Research Council (UK) and the Wellcome Trust for research on depression and inflammation as part of two large consortia that also include Johnson & Johnson, GSK and Lundbeck.