Evidence map›Paper›PMID 23147384›Full record

Trial reportMolecular psychiatry2013

Effects of the mu-opioid receptor antagonist GSK1521498 on hedonic and consummatory eating behaviour: a proof of mechanism study in binge-eating obese subjects.

H Ziauddeen, S R Chamberlain, P J Nathan, A Koch, K Maltby, M Bush, W X Tao, A Napolitano, A L Skeggs, A C Brooke and 10 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Molecular psychiatry, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01195792 (A 35-Day, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate the Effects of GSK1521498 on Body Weight and Composition, Eating Behaviour and Related Brain Function, in Obese Subjects With Over-Eating Behaviours.), which is not on this map. Cited by 53 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 2 pooled it
10.5field-weighted citation impact, top 2% 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.

NCT01195792 phase2completednot on this map

A 35-Day, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate the Effects of GSK1521498 on Body Weight and Composition, Eating Behaviour and Related Brain Function, in Obese Subjects With Over-Eating Behaviours.

TypeinterventionalSponsorGlaxoSmithKlineRan2010 to 2011Enrolled60ConditionsObesityArmsGSK1521498, Placebo
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 2 syntheses or guidelines pooled it, 104 citations in OpenAlex.

  1. Pooled it
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  11. Current perspectives on brain circuits involved in food addiction-like behaviors.Journal of neural transmission (Vienna, Austria : 1996) · 2024
    Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Cerebral μ-opioid and CBTranslational psychiatry · 2021
    Article
  19. Review
  20. Review
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

20 authors at 5 institutions in 2 countries.

H Ziauddeen1] Medicines Discovery and Development, GlaxoSmithKline, Clinical Unit Cambridge, Addenbrooke's Centre for Clinical Investigations, Cambridge, UK [2] Department of Psychiatry, Behavioural & Clinical Neuroscience Institute, Cambridge Biomedical Campus, University of Cambridge, Cambridge, UK [3] Metabolic Research Laboratories, Institute of Metabolic Science, University of Cambridge, Cambridge, UK [4] Cambridgeshire and Peterborough NHS Foundation Trust (CPFT), Cambridge, UK.
S R Chamberlain
P J Nathan
A Koch
K Maltby
M Bush
W X Tao
A Napolitano
A L Skeggs
A C Brooke
L Cheke
N S Clayton
I Sadaf Farooqi
S O'Rahilly
D Waterworth
K Song
L Hosking
D B Richards
P C Fletcher
E T Bullmore
GlaxoSmithKline (United Kingdom) · GBUniversity of Cambridge · GBGlaxoSmithKline (United States) · USCambridgeshire and Peterborough NHS Foundation Trust · GBWellcome/MRC Institute of Metabolic Science · GB

Funding

Medical Research Council G0600717Medical Research Council G0900554Medical Research Council G9824984Wellcome Trust 095692Wellcome Trust 100574
6 · The paper itself

Abstract

The opioid system is implicated in the hedonic and motivational processing of food, and in binge eating, a behaviour strongly linked to obesity. The aim of this study was to evaluate the effects of 4 weeks of treatment with the mu-opioid receptor antagonist GSK1521498 on eating behaviour in binge-eating obese subjects. Adults with body mass index ≥ 30 kg m(-2) and binge eating scale scores ≥ 19 received 1-week single-blind placebo run-in, and were then randomized to 28 days with either 2 mg day(-1) GSK1521498, 5 mg day(-1) GSK1521498 or placebo (N=21 per arm) in a double-blind parallel group design. The outcome measures were body weight, fat mass, hedonic and consummatory eating behaviour during inpatient food challenges, safety and pharmacokinetics. The primary analysis was the comparison of change scores in the higher-dose treatment group versus placebo using analysis of covariance at each relevant time point. GSK1521498 (2 mg and 5 mg) was not different from placebo in its effects on weight, fat mass and binge eating scores. However, compared with placebo, GSK1521498 5 mg day(-1) caused a significant reduction in hedonic responses to sweetened dairy products and reduced calorific intake, particularly of high-fat foods during ad libitum buffet meals, with some of these effects correlating with systemic exposure of GSK1521498. There were no significant effects of GSK1521498 2 mg day(-1) on eating behaviour, indicating dose dependency of pharmacodynamics. GSK1521498 was generally well tolerated and no previously unidentified safety signals were detected. The potential for these findings to translate into clinically significant effects in the context of binge eating and weight regain prevention requires further investigation.

Indexed as

AdolescentAdultBulimiaDose-Response Relationship, DrugDouble-Blind MethodFeeding BehaviorFemaleHumansIndansMaleMiddle AgedReceptors, Opioid, muTriazolesYoung AdultIndansN-((3,5-difluoro-3'-(1H-1,2,4-triazol-3-yl)-4-biphenylyl)methyl)-2,3-dihydro-1H-inden-2-amineReceptors, Opioid, muTriazoles

Identifiers

PMID23147384
PMCPMC3835938
OpenAlexW2008878559

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.