Evidence map›Paper›PMID 31747930›Full record

ArticleTrials2019

Liraglutide and the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first-episode psychosis: protocol for a pilot trial.

Clare Alexandra Whicher, Hermione Clare Price, Peter Phiri, Shanaya Rathod, Katharine Barnard-Kelly, Claire Reidy, Kerensa Thorne, Carolyn Asher, Robert Peveler, Joanne McCarthy and 1 more

Open access · goldFull text readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 7% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
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

11 authors at 3 institutions in 1 country.

Clare Alexandra WhicherSouthern Health NHS Foundation Trust, Research and Development Department Tom Rudd Unit, Moorgreen Hospital, Botley Rd, West End, Southampton, SO30 3JB, UK. Clare.whicher@southernhealth.nhs.uk.ORCID http://orcid.org/0000-0002-2003-1459
Hermione Clare PriceSouthern Health NHS Foundation Trust, Research and Development Department Tom Rudd Unit, Moorgreen Hospital, Botley Rd, West End, Southampton, SO30 3JB, UK.
Peter PhiriSouthern Health NHS Foundation Trust, Research and Development Department Tom Rudd Unit, Moorgreen Hospital, Botley Rd, West End, Southampton, SO30 3JB, UK.
Shanaya RathodSouthern Health NHS Foundation Trust, Research and Development Department Tom Rudd Unit, Moorgreen Hospital, Botley Rd, West End, Southampton, SO30 3JB, UK.
Katharine Barnard-KellyBarnard Health Research Limited, 42 Kilmiston Drive, Porchester, Fareham, PO16 8EG, UK.
Claire ReidySchool of Health Sciences, Faculty of Environmental and Life Sciences, University of Southampton, Tremona Road, Southampton, SO16 6YD, UK.
Kerensa ThorneSouthern Health NHS Foundation Trust, Research and Development Department Tom Rudd Unit, Moorgreen Hospital, Botley Rd, West End, Southampton, SO30 3JB, UK.
Carolyn AsherSouthern Health NHS Foundation Trust, Research and Development Department Tom Rudd Unit, Moorgreen Hospital, Botley Rd, West End, Southampton, SO30 3JB, UK.
Robert PevelerLiaison Psychiatry, College Keep, Terminus Terrace, Southampton, SO14 3DT, UK.
Joanne McCarthySouthern Health NHS Foundation Trust, Research and Development Department Tom Rudd Unit, Moorgreen Hospital, Botley Rd, West End, Southampton, SO30 3JB, UK.
Richard Ian Gregory HoltHuman Development and Health Academic Unit, Faculty of Medicine, University of Southampton, Tremona Road, Southampton, SO16 6YD, UK.
Southern Health NHS Foundation Trust · GBUniversity of Southampton · GBBarnardo's · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeople with severe mental illness (SMI) are two to three times more likely to be overweight and obese than the general population and this is associated with significant morbidity and premature mortality. Although lifestyle interventions can support people with SMI to lose weight, some are unable to make the necessary lifestyle changes or, despite making the changes, continue to gain weight.

objectiveTo assess the feasibility and acceptability of delivering a full-scale trial evaluating whether liraglutide 3.0 mg, a once-daily injectable therapy, may be an effective treatment of overweight and obesity in people with schizophrenia, schizoaffective disorder and first-episode psychosis.

methodsDesign: a single-centre, double-blind, randomised, placebo-controlled trial.

settingmental health facilities within Southern Health NHS Trust.

participants60 adults with schizophrenia, schizoaffective or first-episode psychosis prescribed antipsychotic medication will be recruited. Participants will be overweight or obese, defined by their baseline BMI which will be: • BMI ≥ 30 kg/m

interventionparticipants will be allocated in a 1:1 ratio using a computer-based randomisation programme to either once-daily subcutaneously administered liraglutide or placebo, titrated to 3.0 mg daily, for 6 months. All participants will receive standardised written information about healthy eating and exercise at their randomisation visit. OUTCOMES: the main aim of the study is to gather data on recruitment, consent, retention and adherence. Qualitative interviews with a purposive sub-sample of participants and healthcare workers will provide data on intervention feasibility and acceptability. Secondary clinical outcome measurements will be assessed at 3 and 6 months and will include: weight, fasting plasma glucose, lipid profile, HbA DISCUSSION: This study should provide evidence of the potential benefits of liraglutide (maximum dosage 3.0 mg daily) on body weight and metabolic variables in people with schizophrenia, schizoaffective disorder and first-episode psychosis. It will also address the feasibility and acceptability of the use of liraglutide in mental health settings. This will inform the design of a longer outcome study that will be needed to determine whether any weight loss can be maintained in the long term.

trial registrationUniversal Trial Number (UTN), ID: U1111-1203-0068. Registered on on 2/10/2017. European Clinical Trials Database (EudraCT), ID: 2017-004064-35. Registered on 3/10/2017.

Indexed as

Randomized Controlled Trials as TopicAdolescentAdultAffective Disorders, PsychoticAgedDouble-Blind MethodHumansLiraglutideMiddle AgedObesityOverweightPilot ProjectsPsychotic DisordersSchizophreniaYoung AdultLiraglutideFeasibilityLiraglutideObesityOverweightPilotSchizophreniaSevere mental illness

Identifiers

PMID31747930
PMCPMC6868690
OpenAlexW2989944160

What OpenQuestion holds

Textfull text, public
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.