CRediT contribution statement
Hamish McAllister-Williams (https://orcid.org/0000-0001-9966-1834): Conceptualisation, Funding acquisition, Project administration, Supervision, Writing – original draft, Writing – reviewing and editing.
Nicola Goudie (https://orcid.org/0000-0003-1211-936X): Project administration, Writing – original draft, Writing – reviewing and editing.
Lumbini Azim (https://orcid.org/0000-0003-3094-5366): Writing – original draft, Investigation, Data curation, Formal analysis, Writing – reviewing and editing.
Victoria Bartle (https://orcid.org/0000-0001-8206-5016): Project administration, Conceptualisation, Investigation, Data curation, Formal analysis, Writing – original draft, Writing – reviewing and editing, Other contributions.
Michael Berger (https://orcid.org/0000-0002-1183-8410): Data curation, Formal analysis, Methodology, Visualisation, Writing – original draft, Writing – reviewing and editing.
Chrissie Butcher (https://orcid.org/0000-0002-1696-1506): Project administration, Writing – reviewing and editing.
Thomas Chadwick (https://orcid.org/0000-0002-7995-0302): Conceptualisation, Funding acquisition, Data curation, Methodology, Formal analysis, Writing – original draft, Writing – reviewing and editing.
Emily Clare (https://orcid.org/0000-0003-4168-9185): Writing – reviewing and editing, Investigation.
Paul Courtney (https://orcid.org/0000-0003-4147-4846): Conceptualisation, Funding acquisition, Investigation, Writing – reviewing and editing.
Lyndsey Dixon (https://orcid.org/0009-0004-8351-7060): Project administration, Writing – reviewing and editing, Other contributions.
Nichola Duffelen (https://orcid.org/0000-0002-5340-6931): Writing – reviewing and editing, Other contributions.
Tony Fouweather (https://orcid.org/0000-0002-2292-0495): Methodology, Data curation, Formal analysis, Visualisation, Writing – original draft, Writing – reviewing and editing.
William Gann (https://orcid.org/0000-0003-3395-8250): Writing – reviewing and editing, Investigation.
John Geddes (https://orcid.org/0000-0002-5281-5960): Conceptualisation, Funding acquisition, Writing – reviewing and editing.
Sumeet Gupta (https://orcid.org/0000-0003-1586-5069): Writing – reviewing and editing, Investigation.
Beth Hall (https://orcid.org/0000-0002-5812-3121): Writing – reviewing and editing, Investigation.
Timea Helter (https://orcid.org/0000-0002-2696-2553): Data curation, Methodology, Writing – reviewing and editing.
Paul Hindmarch (https://orcid.org/0000-0001-8775-3600): Writing – reviewing and editing, Investigation.
Eva-Maria Holstein (https://orcid.org/0000-0002-3027-9052): Writing – reviewing and editing, Project administration.
Ward Lawrence (https://orcid.org/0000-0002-9563-7754): Writing – reviewing and editing, Investigation.
Phil Mawson (https://orcid.org/0000-0002-2056-5047): Writing – reviewing and editing, Project administration.
Iain McKinnon (https://orcid.org/0000-0002-5760-9824): Writing – reviewing and editing, Methodology, Supervision, Formal analysis.
Adam Milne (https://orcid.org/0000-0002-5656-5647): Writing – reviewing and editing, Project administration.
Aisling Molloy (https://orcid.org/0000-0002-0078-4787): Writing – reviewing and editing, Other contributions.
Abigail Moore (https://orcid.org/0000-0002-8293-0732): Project administration, Writing – original draft, Writing – reviewing and editing.
Richard Morriss (https://orcid.org/0000-0003-2910-4121): Conceptualisation, Funding acquisition, Methodology, Writing – reviewing and editing, Investigation.
Anisha Nakulan (https://orcid.org/0009-0001-0659-6971): Writing – reviewing and editing, Investigation, Formal analysis.
Judit Simon (https://orcid.org/0000-0001-9279-8627): Conceptualisation, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Resources, Supervision, Visualisation, Writing – original draft, Writing – reviewing and editing.
Daniel Smith (https://orcid.org/0000-0002-2267-1951): Conceptualisation, Funding acquisition, Writing – reviewing and editing.
Bryony Stokes-Crossley (https://orcid.org/0000-0002-7265-6223): Project administration, Writing – reviewing and editing, Other contributions.
Paul Stokes (https://orcid.org/0000-0002-2274-8330): Conceptualisation, Funding acquisition, Writing – reviewing and editing, Investigation.
Andrew Swain (https://orcid.org/0000-0002-7770-7341): Project administration, Writing – original draft, Writing – reviewing and editing.
Zoë Walmsley (https://orcid.org/0000-0002-1253-6668): Writing – reviewing and editing, Project administration.
Christopher Weetman (https://orcid.org/0000-0002-6372-0393): Writing – reviewing and editing, Data curation.
Allan H Young (https://orcid.org/0000-0003-2291-6952): Conceptualisation, Funding acquisition, Writing – reviewing and editing.
Stuart Watson (https://orcid.org/0000-0002-2558-3367): Conceptualisation, Funding acquisition, Supervision, Writing – reviewing and editing, Investigation.
Acknowledgements
The PAX-BD trial was only possible due to the generous support from an extensive number of individuals.
Patient and public involvement and engagement input was critical to the development of the research plans from prior to the grant application stage, through production of the study protocol, development of study documentation (especially that which was patient-facing), recruitment and training of RAs and reviewing and analysis of the data. The PPIE group members were part of the investigation team but deserve special mention for all of their invaluable input. Special mention goes to the initial PPIE group chair and TMG member, Sandy Harvey, who sadly passed away during the course of the study. Her passion and support for the study and the participants taking part in it greatly impacted how the study ran and on all of the study personnel involved in it. The outputs from the study are part of her legacy to us all.
The investigators would like to acknowledge the NIHR CRNs who provided NHS research support to the trial.
Clinicians and research teams from across England and Scotland contributed to the trial at individual sites and we express our gratitude to all site staff for their support of trial recruitment and data collection. We would like to thank the following centres:
• Avon and Wiltshire Mental Health Partnership NHS Trust
• Cheshire and Wirral Partnership NHS Foundation Trust
• Cumbria, Northumberland, Tyne and Wear NHS Trust
• Derbyshire Healthcare NHS Foundation Trust
• Devon Partnership NHS Trust
• Essex Partnership University NHS Foundation Trust
• Kent and Medway NHS and Social Care Partnership Trust
• Lancashire and South Cumbria NHS Foundation Trust
• Leicestershire Partnership NHS Trust
• Lincolnshire Partnership NHS Foundation Trust
• NHS Lothian
• NHS Greater Glasgow and Clyde
• NHS Tayside
• Nottinghamshire Healthcare NHS Foundation Trust
• Oxford Health NHS Foundation Trust
• Sheffield Health and Social Care NHS Foundation Trust
• South London and Maudsley NHS Foundation Trust
• Surrey and Borders Partnership NHS Foundation Trust
• Southwest Yorkshire Partnership NHS Foundation Trust
• Southwest London and St George’s Mental Health NHS Trust
• Tees, Esk and Wear Valleys NHS Foundation Trust
We would also like to thank all the site staff who have taken part in the qualitative interviews.
We would also like to thank the NCTU staff, including previous team members – Senior Trial Managers Jared Thornton and Jenn Walker and Trial Managers Dominique French, Gillian Watson, Faye Wolstenhulme, Georgiana Brown and Jenny McCarthy.
Trial Steering Committee members
We would like to thank the members of the TSC:
Dr Jill Rasmussen (Chair), Dr Angus Forsyth, Professor Ted Dinan, Dr Jeff Round, Dr Hilary Watt and Ms Jane Cranston.
Data Monitoring Committee members
We thank the members of the DMC for all their valuable guidance: Professor Carl Clarke (Chair), Ms Smitaa Patel, Dr Helene Brandon, Miss Rebecca Woolley and Professor Ian Anderson.
Finally, but most importantly, we would like to thank all our participants for taking part in the PAX-BD trial.
Patient data statement
This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that they are stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.
Data-sharing statement
Anonymised data from this trial may be available to the scientific community subject to regulatory and ethics approval. Requests for data should be directed to the corresponding author.
Ethics statement
This trial received ethical approval on 4 September 2019 from the North East – Newcastle and North Tyneside 2 Research Ethics Committee: 19/NE/0233.
Information governance statement
Cumbria, Northumberland, Tyne and Wear is committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679. Under the Data Protection legislation, CNTW is the Data Controller, and you can find out more about how we handle personal data, including how to exercise your individual rights and the contact details for our Data Protection Officer here (www.cntw.nhs.uk/foi/data-protection/).
Disclosure of interests
Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/HBFC1953.
Primary conflicts of interest: Hamish McAllister-Williams reports acting as TSC chair for the NIHR HTA funded SNAPPER trial and DMC chair for the EU funded PReDicT study; Director of Education for British Association for Psychopharmacology; receiving support for meetings via Janssen-Cilag; receiving payments/consultation fees from LivaNova, Janssen-Cilag, Sage Therapeutics, P1Vital, Takeda and Lundbeck.
Thomas Chadwick reports payments from NIHR HTA and the following:
Member of Programme Steering Committee (ODDESSI: Open Dialogue: Development and Evaluation of a Social Network Intervention for Severe Mental Illness – University College London); Chair of Data Monitoring and Ethics Committee (SCENE: Improving quality of life and health outcomes of patients with psychosis through a new structured intervention for expanding social networks – Queen Mary University of London); Member of Data Monitoring and Ethics Committee (SUMMIT: SUpporting Mothers’ Mental health with Interpersonal Therapy – University College London).
Sumeet Gupta reports receiving support/payments/consultation fees from Janssen and Mylan.
Aisling Molloy reports participation in the PAX-BD TMG from 2021 to 2022, payment for writing an article on safe prescribing of lithium in primary care via Prescriber journal, pending payment for review of MPharm bipolar and unipolar depression slides from Sunderland University.
Richard Morriss reports payments made to institution from NIHR HTA programme, UKRI-MRC, UKRI-ESPRC, Wellcome Trust, Magstim plc, Electromedical Products Inc, P1Vital Ltd.
Judit Simon reports being PI/co-I on research grants with payments made to the Medical University of Vienna from the NIHR, EC Horizon 2020, EC Horizon Europe, ECNP, LBG, WWTF, FWF, and advisory honoraria received by the EBC in the past 5 years.
Paul Stokes reports payments made to institution from NIHR as a co-app on the PAX-BD trial, MRC UK, H. Lundbeck A/S and NIHR, membership of the UK Advisory Council for the Misuse of Drugs and Royal College of Psychiatrists Academic Faculty executive committee, NIHR CRN South London Speciality Lead for Mental Health and Speciality Chief Editor, Mood Disorders section, Frontiers in Psychiatry, membership of the International Society for Bipolar Disorders Targeting Cognition and Chronobiology taskforces, study medications provided for MRC grant and non-financial support for an MRC-funded study edited by himself from Janssen Research and Development LLC and editorial honoraria from Frontiers in Psychiatry.
Allan H Young reports acting as PI on the following studies Restore-Life VNS registry study; ESKETINTRD3004; The Effects of Psilocybin on Cognitive Function in Healthy Participants; P-TRD, as UK CI Compass; COMP006; COMP007; Novartis MDD study MIJ821A1220, conducting paid lectures and advisory boards for the following companies with drugs used in affective and related disorders: AstraZeneca, Boehringer Ingelheim, Eli Lilly, LivaNova, Lundbeck, Sunovion, Servier, Livanova, Janssen, Allegan, Bionomics, Sumitomo Dainippon Pharma, COMPASS, Sage, Novartis, Neurocentrx, being a Trustee Drug Safety Research Unit, Editor of Journal of Psychopharmacology and Deputy Editor BJ Psych Open, and being on the Executive Committee for British Association Psychopharmacology and International Society for Affective Disorders.
Stuart Watson reports honoraria payments from BAP mood disorders certificate teaching and NIHR HTA board funding.
Publications
Azim L, Hindmarch P, Browne G, Chadwick T, Clare E, Courtney P, et al. Study protocol for a randomised placebo-controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression (the PAX-BD study). BMC Psychiatry 2021;21:334. https://doi.org/10.1186/s12888-021-03322-y
McAllister-Williams RH, Goudie N, Azim L, Bartle V, Berger M, Butcher C, et al. A randomised double-blind, placebo-controlled trial of pramipexole in addition to mood stabilisers for patients with treatment-resistant bipolar depression (the PAX-BD study). J Psychopharmacol 2025;39(2):106–20. https://doi.org/10.1177/02698811241309622
Disclaimers
This article presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care.