Ethics approval and consent to participate
OPEN received a favourable Research Ethics Committee (REC) opinion from the Research Ethics Committees Northern Ireland (ORECNI) on 10/03/2022; REC reference: 22/NI/0010; IRAS project ID: 295297. Before inclusion into the study, informed consent was obtained from each participant who was 16 years old or older. Children and adolescents who were younger than 16 years were asked to give their informed assent before inclusion into the study, and additional informed consent was obtained from their parents. We conducted this investigation following the Helsinki Declaration’s guiding principles. This study has been registered with the International Standard Randomised Controlled Trial Number (ISRCTN) register on the 27/04/2022 under the unique identification number ISRCTN80075010. Current Protocol version 1.3; 2 December 2022.
Consent for publication
Not applicable. This manuscript reports results from anonymized data only.
Availability of data
Ethical approval and the obtained consent from study participants did not include public availability of the data. However, the data are available from the corresponding author upon reasonable request.
Competing interest
HH is the Principal Investigator on “Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study,” a COMPASS Pathways-funded and -sponsored proof-of-concept study testing psilocybin in AN.
AHY participated in paid lectures and advisory boards for the following companies: Allegan, AstraZeneca, Bionomics Ltd, Boehringer Ingelheim, COMPASS, Eli Lilly, Janssen, LivaNova, Lundbeck, Neurocentrx, Novartis, Sage, Servier, Sumitomo Dainippon Pharma, and Sunovion. AHY is the 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)’; UK Chief Investigator for Novartis MDD study MIJ821A12201.
All other authors declare no competing interests.
Funding
This study was funded by the National Institute for Health Research (NIHR) Evaluation, Trials and Studies Coordinating Centre (NETSCC) Health Technology Assessment (HTA) Programme (project reference NIHR130780). King's College London (KCL) is the lead sponsor and South London and Maudsley NHS Foundation Trust (SLaM) is the cosponsor for this study. The sponsors act as data controllers.
This research was supported by the National Institute for Health and Care Research (NIHR) Maudsley Biomedical Research Centre. US, JT, SL and HH receive salary support from NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust (SLaM) and KCL. SL is also supported by the Applied Research Collaboration (ARC), South London. DN is supported by the NIHR ARC Northwest London, and the NIHR Imperial BRC. The views expressed are those of the authors and not necessarily those of the NIHR, the National Health Service (NHS), the Department of Health and Social Care or the NHMRC. This work is also supported by the MRC/AHRC/ESRC Adolescence, Mental Health and the Developing Mind initiative as part of the EDIFY programme (grant number MR/W002418/1).
Authors' contributions
HH, JT, US, BC, DS, MS, DS, SL, JB, AHY, SB, SM and VL planned the study design. OS, ESF, DS, HM, SB, MNA, VK, KI, ETB, DBM, JWTK, LA, JB, NK, BC, MS, VL, JT, US, DN and HH conducted the study. DS, BC, and SL evaluated the data. OS, ESF, DS and HH drafted the manuscript. All authors made contributions to the interpretation of the study results, were involved in the revision of the manuscript, participated in, and approved the final manuscript.
Acknowledgements
We thank the NIHR Research Design Service London for their advice on study design.
We also thank the members of the Data Monitoring Committee (John Roche, Charlotte Scott, Rebecca Woolley) and the Trial Steering Committee (Helen E. Bould, Paul Robinson, Michael Kluge, Stephany Fulda, Jessica Bentley, Aylin Unlu) for contributing their time and valuable expertise to the oversight of the project.
We would like to thank all colleagues from the participating NHS Trusts for their effort to recruit study participants; in particular, we would like to thank Paula Herrera-Gener, Camilla Day, Nikola Kern, Natalie Pretorius, Leola Cruden-Smith, Nacharin Phiphopthatsanee, Mutlu Tacihan Uygur, Camilla Mills, Annika Ray, Demelza Beishon-Murley, Carol Kan, Frances Connan, Rebecca Neale, Rosalind Byles, Rebecca Cowan, Elizabeth Fofana, Irene Bishton, Hazel Burt, Carla Figueiredo, Katarzyna Malczuk, Zofia Bronowska, Sam Clark-Stone, Francesca Hill, Elizabeth Dodd, Ruth Dawson and Lina Hamoudi.
OPEN has a separate sister study planned in Australia, which aims to recruit 15 participants. The study was planned in two countries to allow for differences in healthcare systems and care processes to be explored. The study protocols are largely similar, with separate ethics approval, funding and sponsorship. The Australian part of the study was approved by the Sydney Children Hospitals Network Human Research Ethics Committee (HREC reference 2021/ETH01321) on 20 September 2021 and has been funded by the National Health and Medical Research Council (NHMRC). The sponsor is the University of Sydney. The current article refers exclusively to the OPEN study performed in the UK.