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)
Year: 2021
Type: article
Study design: Study Protocol
Abstract: BACKGROUND: Treatment Resistant Bipolar Depression (TRBD) is a major contributor to the burden of disease associated with Bipolar Disorder (BD). Treatment options for people experiencing bipolar depression are limited to three interventions listed by National Institute for Health and Care: lamotrigine, quetiapine and olanzapine, of which the latter two are often not well tolerated. The majority of depressed people with BD are therefore prescribed antidepressants despite limited efficacy. This demonstrates an unmet need for additional interventions. Pramipexole has been shown to improve mood symptoms in animal models of depression, in people with Parkinson's Disease and two proof of principle trials of pramipexole for people with BD who are currently depressed. METHODS: The PAX-BD study, funded by the United Kingdom (UK) National Institute for Health Research, aims to extend previous findings by assessing the efficacy, safety and health economic impact of pramipexole in addition to mood stabilisers for patients with TRBD. A randomised, double-blind, placebo controlled design is conducted in a naturalistic UK National Health Service setting. An internal pilot study to examine feasibility and acceptability of the study design is included. Participants with TRBD are screened from National Health Service secondary care services in up to 40 mental health trusts in the UK, with the aim of recruiting approximately 414 participants into a pre-randomisation phase to achieve a target of 290 randomised participants. Primary safety and efficacy measures are at 12 weeks following randomisation, with follow up of participants to 52 weeks. The primary outcome is depressive symptoms as measured by Quick Inventory for Depressive Symptomatology - Self Report. Secondary outcomes include changes in anxiety, manic symptoms, tolerability, acceptability, quality of life and cost-effectiveness. Outcome measures are collected remotely using self-report tools implemented online, and observer-rated assessments conducted via telephone. ANCOVA will be used to examine the difference in rating scale scores between treatment arms, and dependent on compliance in completion of weekly self-report measures. A mixed effects linear regression model may also be used to account for repeated measures. TRIAL REGISTRATION: ISRCTN72151939. Registered on 28 August 2019, http://www.isrctn.com/ISRCTN72151939 Protocol Version: 04-FEB-2021, Version 9.0.
Source: BMC Psychiatry
Authors: Lumbini Azim, Paul Hindmarch, Georgiana Browne, Thomas Chadwick, Emily Clare, Paul Courtney, Lyndsey Dixon, Nichola Duffelen, Tony Fouweather, John R. Geddes, Nicola Goudie, Sandy Harvey, Timea Helter, Eva-Maria Holstein, Garry Martin, Phil Mawson, Jenny McCaffery, Richard Morriss, Judit Simon, Daniel Smith, Paul R. A. Stokes, Jenn Walker, Chris Weetman, Faye Wolstenhulme, Allan H. Young, Stuart Watson, R. Hamish McAllister-Williams
Institutions: Cumbria Northumberland Tyne and Wear NHS Foundation Trust, Newcastle University, Oxford Health NHS Foundation Trust, University of Oxford, Newcastle upon Tyne Hospitals NHS Foundation Trust, Academic Health Science Network North East and North Cumbria, Medical University of Vienna, University of Nottingham, University of Glasgow, King's College London, South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, Newcastle Hospitals - Campus for Ageing and Vitality
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,590
Funders: Eli Lilly and Company, Pfizer, South London and Maudsley NHS Foundation Trust, Sunovion, LivaNova, National Institute for Health and Care Research, King's College London, University of Oxford, Newcastle University, University of Glasgow, Universität Wien, Newcastle upon Tyne Hospitals NHS Foundation Trust, Medizinische Universität Wien, Fakultet Medicinskih Nauka, Univerziteta U Kragujevcu, Servier, H. Lundbeck A/S, Oxford Health NHS Foundation Trust, Allergan, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, Medical Research Council, Health Technology Assessment Programme, Faculty of Medical Sciences, Newcastle University, Janssen Research and Development, Cilag
OpenAlex ID: W3180624618