Evidence map›Paper›PMID 30214156›Full record

Trial reportDrug design, development and therapy2018

Asenapine pharmacokinetics and tolerability in a pediatric population.

Peter Dogterom, Robert Riesenberg, Rik de Greef, Justin Dennie, Martin Johnson, Venkatesh Pilla Reddy, André Mm Miltenburg, Robert L Findling, Abhijeet Jakate, Timothy J Carrothers and 1 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2018. 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
0.2field-weighted citation impact, top 45% 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

2 citing papers in PubMed, 12 citations in OpenAlex.

  1. Oral Health in Individuals with Severe Mental Illness on Second-Generation Antipsychotics-A Scoping Review.Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology · 2025
    Article
  2. 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

11 authors at 4 institutions in 2 countries.

Peter DogteromEarly Stage Development, Merck Sharp and Dohme, Oss, the Netherlands, peter.dogterom@qps.com.
Robert RiesenbergAtlanta Center for Medical Research, Atlanta, GA.
Rik de GreefEarly Stage Development, Merck Sharp and Dohme, Oss, the Netherlands, peter.dogterom@qps.com.
Justin DennieMerck, Kenilworth, NJ.
Martin JohnsonEarly Stage Development, Merck Sharp and Dohme, Oss, the Netherlands, peter.dogterom@qps.com.
Venkatesh Pilla ReddyEarly Stage Development, Merck Sharp and Dohme, Oss, the Netherlands, peter.dogterom@qps.com.
André Mm MiltenburgEarly Stage Development, Merck Sharp and Dohme, Oss, the Netherlands, peter.dogterom@qps.com.
Robert L FindlingKennedy Krieger Institute, Johns Hopkins University, Baltimore, MD.
Abhijeet JakateAllergan, Madison, NJ, USA.
Timothy J CarrothersAllergan, Madison, NJ, USA.
Matthew D TroyerMerck, Kenilworth, NJ.
MSD (Netherlands) · NLAllergan (United States) · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USKennedy Krieger Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study aimed to characterize the pharmacokinetic (PK) properties, safety, and tolerability of asenapine, and to develop a population PK model in pediatric patients with schizophrenia, bipolar disorder, or other psychiatric disorders.

methodsTwo Phase I multiple ascending-dose studies were conducted to evaluate the PK, safety, and tolerability of sublingual asenapine in pediatric patients (age 10-17 years) with schizophrenia or bipolar I disorder. Patients received asenapine 1-10 mg twice daily for up to 12 days. PK parameters (maximum concentration [C

resultsThe PK of asenapine showed rapid absorption (T

conclusionAsenapine was generally safe and well tolerated in pediatric patients aged 10-17 years. PK and safety data were similar to that observed in the adult population. Intrinsic factors had no significant impact on asenapine exposure, indicating there is no need for dose adjustments in the pediatric population.

Indexed as

AdolescentAntipsychotic AgentsChildDibenzocycloheptenesFemaleHeterocyclic Compounds, 4 or More RingsHumansMaleMental DisordersAntipsychotic AgentsasenapineDibenzocycloheptenesHeterocyclic Compounds, 4 or More Ringsasenapineatypical antipsychoticbipolar disorderchild and adolescentpharmacokineticsschizophrenia

Identifiers

PMID30214156
PMCPMC6124477
OpenAlexW2889256685

What OpenQuestion holds

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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.