Evidence map›Paper›PMID 34225686›Full record

ArticleBMC psychiatry2021

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).

Lumbini Azim, Paul Hindmarch, Georgiana Browne, Thomas Chadwick, Emily Clare, Paul Courtney, Lyndsey Dixon, Nichola Duffelen, Tony Fouweather, John R Geddes and 17 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 8 institutions in 2 countries.

Lumbini AzimCumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, UK.
Paul HindmarchCumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, UK.
Georgiana BrowneNewcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.
Thomas ChadwickBiostatistics Research Group, Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle, UK.
Emily ClareCumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, UK.
Paul CourtneyCumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, UK.
Lyndsey DixonCumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, UK.
Nichola DuffelenCumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, UK.
Tony FouweatherBiostatistics Research Group, Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle, UK.
John R GeddesDepartment of Psychiatry, University of Oxford, Oxford, UK.
Nicola GoudieNewcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.
Sandy HarveyPatient, Carer and Public Involvement, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Timea HelterDepartment of Health Economics, Center for Public Health, Medical University of Vienna, Vienna, Austria.
Eva-Maria HolsteinNewcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.
Garry MartinCumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, UK.
Phil MawsonNewcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.
Jenny McCafferyNewcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.
Richard MorrissDivision of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.
Judit SimonDepartment of Psychiatry, University of Oxford, Oxford, UK.
Daniel SmithInstitute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Paul R A StokesDepartment of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London & South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, London, UK.
Jenn WalkerNewcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.
Chris WeetmanNewcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.
Faye WolstenhulmeNewcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.
Allan H YoungDepartment of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London & South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, London, UK.
Stuart WatsonCumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, UK.
R Hamish McAllister-WilliamsCumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, UK. Hamish.McAllister-Williams@newcastle.ac.uk.ORCID 0000-0001-9966-1834
Newcastle University · GBCumbria Northumberland Tyne and Wear NHS Foundation Trust · GBKing's College London · GBNewcastle upon Tyne Hospitals NHS Foundation Trust · GBMedical University of Vienna · ATOxford Health NHS Foundation Trust · GBUniversity of Glasgow · GBUniversity of Nottingham · GB

Funding

EPA EP-C-17-031
6 · The paper itself

Abstract

backgroundTreatment 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.

methodsThe 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 registrationISRCTN72151939. Registered on 28 August 2019, http://www.isrctn.com/ISRCTN72151939 Protocol Version: 04-FEB-2021, Version 9.0.

Indexed as

Bipolar DisorderCost-Benefit AnalysisHumansPilot ProjectsPramipexoleQuality of LifeRandomized Controlled Trials as TopicState MedicineUnited KingdomPramipexoleBipolar disorderMood stabilisersPramipexoleTreatment resistant bipolar depression

Identifiers

PMID34225686
PMCPMC8256234
OpenAlexW3180624618

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.