Evidence map›Paper›PMID 31236286›Full record

ArticlePilot and feasibility studies2019

Glycopyrrolate in comparison to hyoscine hydrobromide and placebo in the treatment of hypersalivation induced by clozapine (GOTHIC1): a feasibility study.

Inti Qurashi, Simon Chu, Richard Drake, Victoria Hartley, Imran Chaudhry, J F W Deakin, Nusrat Husain

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02613494 (A Feasibility Study of Glycopyrrolate in Comparison to Hyoscine Hydrobromide and Placebo in the Treatment of Hypersalivation Induced by Clozapine), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 92% 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.

NCT02613494 phase1 / phase2completednot on this map

A Feasibility Study of Glycopyrrolate in Comparison to Hyoscine Hydrobromide and Placebo in the Treatment of Hypersalivation Induced by Clozapine

TypeinterventionalSponsorMersey Care NHS TrustRan2016 to 2018Enrolled29ConditionsSialorrheaArmsHyoscine, Glycopyrrolate, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. 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

7 authors at 2 institutions in 1 country.

Inti QurashiAshworth Hospital, Mersey Care NHS Foundation Trust, Maghull, UK.
Simon ChuAshworth Research Centre, Mersey Care NHS Foundation Trust, Maghull, UK.ORCID 0000-0001-8921-4942
Richard Drake2Faculty of Medicine, Biology and Health, University of Manchester, Manchester, UK.
Victoria HartleyAshworth Research Centre, Mersey Care NHS Foundation Trust, Maghull, UK.
Imran Chaudhry2Faculty of Medicine, Biology and Health, University of Manchester, Manchester, UK.
J F W Deakin2Faculty of Medicine, Biology and Health, University of Manchester, Manchester, UK.
Nusrat Husain2Faculty of Medicine, Biology and Health, University of Manchester, Manchester, UK.
Manchester Academic Health Science Centre · GBUniversity of Lancashire · GB

Funding

Department of Health PB-PG-0214-33069
6 · The paper itself

Abstract

backgroundClozapine-induced hypersalivation (CIH) is a common side effect of clozapine treatment and is disliked by clozapine patients, potentially threatening adherence to clozapine treatment. We proposed a trial of alternative medications, hyoscine and glycopyrrolate, for the treatment of CIH and the primary objective of the feasibility study was to assess the recruitment and retention of community clozapine patients as well as assess the metrics of the primary hypersalivation measure.

methodsThis 11-month trial took place in two NHS trusts in northwest UK. Participants were community-dwelling clozapine patients aged 18-65 years who were suffering from CIH, and were recruited from community mental health clinics. They were randomised using a telephone randomisation service to receive either hyoscine (1 week at 0.6 mg daily, 3 weeks at 0.9 mg daily), glycopyrrolate (1 week at 2 mg daily, 3 weeks at 3 mg daily) or placebo. Participants and investigators were blinded to which study arm the participants had been randomised to. We collected data on salivation levels and side effects on a weekly basis and also assessed cognition at the beginning and end of the trial. We also interviewed a sample of participants after the trial to gather information on their experience of having taken part.

resultsOne hundred and thirty-eight potential participants agreed to being contacted by researchers about participation in the trial and of these, 29 participants were randomised. Of these, four participants exited the trial before taking any trial medication, and two participants left the study owing to concerns of side effects. Data from four participants was missing, and complete data was available for 19 participants who completed the trial. The mean recruitment rate overall was 1.3 participants per site per month, and the overall retention rate was 76%. Interview data suggested that participants' experiences of trial participation were overwhelmingly positive.

conclusionsThe feasibility study demonstrated that a trial of alternative medications in the treatment of CIH is feasible; patients were willing to be randomised to the trial and retention rate was high.

trial registrationClinicalTrials.gov, NCT02613494, registered 24 November 2015.

Indexed as

Clozapine-induced hypersalivationCognitionDroolingFeasibility studyGlycopyrrolateHyoscineRefractory schizophreniaSide effects

Identifiers

PMID31236286
PMCPMC6580560
OpenAlexW2950205252

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

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.