Evidence map›Paper›PMID 41199289›Full record

ArticleTrials2025

A randomised controlled trial to evaluate the clinical and cost-effectiveness of Stimulant compared with Non-stimulant medication for adults with Attention-deficit/hyperactivity disorder and a history of Psychosis or biPolar disordER: SNAPPER.

Shrushma Loi, Paras Joshee, Ryan Ottridge, Rebecca Woolley, Eleni Gkini, Philip Asherson, Allan H Young, Hareth Al-Janabi, Matthew Broome, Anya Roberts and 9 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

19 authors.

Shrushma LoiBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK. s.loi.1@bham.ac.uk.ORCID http://orcid.org/0000-0002-3815-2320
Paras JosheeInstitute for Mental Health, School of Psychology, University of Birmingham, Birmingham, UK.
Ryan OttridgeBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Rebecca WoolleyBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Eleni GkiniBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Philip AshersonInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Allan H YoungInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Hareth Al-JanabiMental Health Humanities, University of Birmingham, Birmingham, UK.
Matthew BroomeInstitute for Mental Health, School of Psychology, University of Birmingham, Birmingham, UK.
Anya RobertsUniversity of Birmingham, Birmingham, UK.
Natalie GottliebInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Paul HindmarchCumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.
Daniel SilmanInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Paritosh SharmaBirmingham and Solihull, NHS Mental Health Trust, Birmingham, UK.
Mario JuruenaInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Rajesh NairCumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.
Tirthankar MukherjeeCheshire and Wirral NHS Partnership NHS Foundation Trust, Chester, UK.
Mohammad Zia Ul Haq KatshuNottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK.
Steven MarwahaInstitute for Mental Health, School of Psychology, University of Birmingham, Birmingham, UK.

Funding

Health Technology Assessment Programme 129817
6 · The paper itself

Abstract

backgroundAttention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder involving inattention, hyperactivity and impulsivity, which starts in childhood and frequently persists into adulthood. Stimulant and non-stimulant medication are the mainstay of treatment in adults. ADHD in adults is commonly comorbid in people with severe mental illness (SMI) such as bipolar disorder (bipolar) and psychosis. There is substantial uncertainty over the effectiveness of stimulant and non-stimulant medication in adult ADHD comorbid with SMI. There is also concern that they could trigger or worsen psychotic or manic symptoms. Whilst National Institute of Health and Care Evidence (NICE) ADHD guidelines indicate available evidence does not justify a deviation from their main recommendations of using stimulants first line, this is based on limited studies within this comorbid population. A randomised controlled trial (RCT) is needed to address this evidence gap. We present a protocol for a pragmatic, observer-blind, multi-centre, two-arm, RCT called SNAPPER that aims to investigate the clinical and cost-effectiveness of stimulant compared with non-stimulant medication for adults with ADHD and a history of SMI.

methodsThe recruitment target is 244 participants, aged 18 years or above, who have a history of SMI (either bipolar disorder or psychosis) with ADHD. Having provided informed consent for screening, participants will undergo validated diagnostic screening assessments to re-confirm the diagnosis of bipolar or psychosis and confirm an ADHD diagnosis. Those with confirmed diagnoses will provide informed consent for entry to the main trial and will then be randomised to receive either stimulant (lisdexamfetamine) or non-stimulant (atomoxetine) medication. The primary outcome measure is observer-rated ADHD symptom severity at 6 months. Secondary outcomes include ADHD symptom severity at 12 months, emergence of symptoms of bipolar or psychosis, health-related quality of life, occupational, daily functioning, substance misuse, cost-effectiveness, adherence, concomitant medication and process outcomes at 6 and 12 months. DISCUSSION: Given that untreated ADHD is associated with poor clinical outcomes, unemployment and criminal justice system involvement, clear evidence in this area is likely to improve recovery for individuals with ADHD and a history of SMI, reducing costs for the individual, the NHS and society.

trial registrationISRCTN79796233. Registered on 19/05/2022.  https://www.isrctn.com/ISRCTN79796233 .

Indexed as

Attention Deficit Disorder with HyperactivityBipolar DisorderCentral Nervous System StimulantsDrug CostsPsychotic DisordersAdultComorbidityCost-Benefit AnalysisHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicTime FactorsTreatment OutcomeCentral Nervous System StimulantsADHDAttention-deficit/hyperactivity disorderBipolar disorderPsychosis

Identifiers

PMID41199289
PMCPMC12590833

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.