Evidence map›Paper›PMID 40879275›Full record

ArticleBritish journal of clinical pharmacology2025

External validation of a therapeutic window for risperidone in children with autism spectrum disorder.

Rebecca A Hermans, Kathalijne Bruens, Karin M Egberts, Birgit C P Koch, Bram Dierckx, Manon H J Hillegers, Marcel Romanos, Regina Taurines, Stefanie Fekete, Khatia Eisenecker and 3 more

Abstract readValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in British journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

13 authors.

Rebecca A HermansDepartment of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, the Netherlands.ORCID https://orcid.org/0000-0001-9622-2246
Kathalijne BruensDepartment of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, the Netherlands.
Karin M EgbertsDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Wurzburg, Germany.
Birgit C P KochDepartment of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, the Netherlands.ORCID https://orcid.org/0000-0002-1202-3643
Bram DierckxDepartment of Child and Adolescent Psychiatry/Psychology, Erasmus University Medical Center, Rotterdam, the Netherlands.
Manon H J HillegersDepartment of Child and Adolescent Psychiatry/Psychology, Erasmus University Medical Center, Rotterdam, the Netherlands.
Marcel RomanosDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Wurzburg, Germany.
Regina TaurinesDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Wurzburg, Germany.
Stefanie FeketeDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Wurzburg, Germany.ORCID https://orcid.org/0000-0003-1925-6228
Khatia EiseneckerDepartment of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Freiburg, Germany.
Hans-Willi ClementDepartment of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Freiburg, Germany.
Christian FleischhakerDepartment of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Freiburg, Germany.
Brenda C M de WinterDepartment of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, the Netherlands.ORCID https://orcid.org/0000-0002-4452-8443

Funding

German Federal Institute of Drugs and Medical Devices (BfArM) 73.05/3832-397285/12Netherlands Organization for Health Research and Development (ZonMW) 836041011
6 · The paper itself

Abstract

Although risperidone is an effective pharmacological intervention for managing disruptive behaviour in children with autism spectrum disorder, it may induce metabolic side effects. This study aimed to externally validate the population pharmacokinetic (popPK) model and the therapeutic window of 3.5-7 ng/mL of risperidone and 9-OH-risperidone, developed with data of the SPACe Study. For this external validation, data from the German Therapeutic Drug Monitoring (TDM) Service and TDM-VIGIL Study was used in nonlinear mixed-effects modelling to evaluate popPK model performance and in receiver operating curve analyses to define the therapeutic window. Population predictions of the popPK model showed underprediction for risperidone concentrations, but individual predictions were fairly accurate. Receiver operating curve analyses resulted in a therapeutic window of 5.0-8.0 ng/mL. The popPK model seems suitable for use in TDM. Because the current analysis included only a few low sum trough concentrations, we suggest maintaining the therapeutic window of 3.5-7.0 ng/mL.

Indexed as

Antipsychotic AgentsAutism Spectrum DisorderDrug MonitoringModels, BiologicalRisperidoneAdolescentChildChild, PreschoolFemaleHumansMaleROC CurveAntipsychotic AgentsRisperidonepaediatricspharmacodynamicspharmacokineticsrisperidonetherapeutic drug monitoring

Identifiers

PMID40879275
PMCPMC12464617

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Registered trials

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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.