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Article History

Received: 9 November 2020

Accepted: 10 June 2021

First Online: 5 July 2021

Declarations

:

: The trial is conducted in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004 and in accordance with the principles of the Declaration of Helsinki. A Clinical Trial Authorisation from the MHRA (Eudract Ref: 2018–002869-18). Approval from the Health Research Authority and a favourable opinion from the NHS Research Ethics Committee (REC: 19/NE/0233) was obtained prior to the start of the study. Investigators, RECs, trial participants and trial registries are notified of protocol amendments as appropriate.The study is run in accordance with the General Data Protection Regulation (May 2018) to safeguard the confidentiality of participants. The trial may be subject to audit by Sponsor representatives or inspection by the MHRA or NIHR HTA. Each investigator site will permit trial-related monitoring, audits and regulatory inspection including access to all essential and source data relating to the trial.Written informed consent is obtained from all participants prior to any study related activities. Staff and participants have the option of opting in or out of qualitative interviews, and participants have the right to withdraw from the study at any time.

: Not applicable.

: LA, GB, EC, LD, ND, TF, NG, SH, TH, PH, EMH, GM, PM, JM, JS, DS, JW, CW and FW have no competing interests.TC: Thomas Chadwick reports grants from NIHR (HTA) during the conduct of the study and outside the submitted work.PC: In last 5 years, Paul Courtney has received speaker fees from Lundbeck. Paul Courtney is a shareholder in GlaxoSmithKline.JRG: JRG in past 5 years has received research funding from MRC, NIHR, Wellcome. JRG is Director of NIHR Oxford Health Biomedical Research Centre and an Emeritus NIHR senior investigator; the views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health.RHMW: In the last 5 years, R. Hamish McAllister-Williams has received fees from American Center for Psychiatry & Neurology United Arab Emirates, British Association for Psychopharmacology, European College of Neuropsychophamracology, International Society for Affective Disorders, Janssen-Cilag ltd, LivaNova, Lundbeck, My Tomorrows, OCM Comunicaziona s.n.c., Pfizer, Qatar International Mental Health Conference, Sunovion, Syntropharma, UK Medical Research Council and Wiley; grant support from NIHR Efficacy and Mechanism Evaluation Panel and HTA Panel; and non-financial support from COMPASS Pathways.RM: Richard Morriss is supported by Nottingham NIHR Biomedical Centre, NIHR MindTech Medical Technology and In Vitro Collaboration and NIHR Applied Research Collaboration East Midlands.PS: Paul Stokes reports grant funding from NIHR HTA, during the conduct of the study. Paul Stokes reports non-financial support from Janssen Research and Development LLC, personal fees from Frontiers in Psychiatry, personal fees from Allergan, grants from H Lundbeck, grants and non-financial support from Corcept Therapeutics, outside the submitted work.SW: Stuart Watson has received speaker fees from Lundbeck, the British Association of Psychopharmacology and NIHR grant support.AY: In the past five years Allan Young has given paid lectures and advisory boards for the following companies with drugs used in affective and related disorders: Astrazenaca, Eli Lilly, Lundbeck, Sunovion, Servier, Livanova, Janssen, Allegan, Bionomics, Sumitomo Dainippon Pharma and COMPASS. AY is Principal Investigator on ESKETINTRD3004: “An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression”, “The Effects of Psilocybin on Cognitive Function in Healthy Participants” and “The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD)”.