Evidence map›Paper›PMID 27726426›Full record

Trial reportJournal of child and adolescent psychopharmacology2016

No Apparent Cardiac Conduction Effects of Acute Treatment with Risperidone in Children with Autism Spectrum Disorder.

Lan Chi Vo, Christopher Snyder, Courtney McCracken, Christopher J McDougle, James T McCracken, Michael G Aman, Elaine Tierney, L Eugene Arnold, Daniel Levi, Michael Kelleman and 4 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of child and adolescent psychopharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 4 pooled it
0.3field-weighted citation impact, top 37% 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

5 citing papers in PubMed, 4 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. 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

14 authors at 8 institutions in 1 country.

Lan Chi Vo1 Department of Psychiatry, Emory University School of Medicine , Atlanta, Georgia .
Christopher Snyder2 Division of Pediatric Cardiology, University Hospitals Rainbow Babies and Children's Hospital , Cleveland, Ohio.
Courtney McCracken3 Children's Hospital of Atlanta & Emory University School of Medicine , Atlanta, Georgia .
Christopher J McDougle4 Harvard Medical School, Massachusetts General Hospital, Lurie Center for Autism , Boston, Massachusetts.
James T McCracken5 Division of Child Psychiatry, University of California at Los Angeles , Los Angeles, California.
Michael G Aman6 Nisonger Center, Ohio State University , Columbus, Ohio.
Elaine Tierney7 Kennedy Krieger Institute , Baltimore, Maryland.
L Eugene Arnold6 Nisonger Center, Ohio State University , Columbus, Ohio.
Daniel Levi8 Mattel Children's Hospital, University of California at Los Angeles , Los Angeles, California.
Michael Kelleman3 Children's Hospital of Atlanta & Emory University School of Medicine , Atlanta, Georgia .
Deirdre Carroll9 Yale Child Study Center, Yale University School of Medicine , New Haven, Connecticut.
John Morrissey8 Mattel Children's Hospital, University of California at Los Angeles , Los Angeles, California.
Benedetto Vitiello10 National Institute of Mental Health , Bethesda, Maryland.
Lawrence Scahill11 Marcus Autism Center, Emory University School of Medicine , Atlanta, Georgia .
The Ohio State University Wexner Medical Center · USCenter for Autism and Related Disorders · USEmory University · USKennedy Krieger Institute · USMattel Children's Hospital · USNational Institute of Mental Health · USUniversity of California, Los Angeles · USYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Emory Psychiatry Clinical Scientist Training Program (CSTP)R25MH101079 · NIMH · EMORY UNIVERSITY · PI GOLDSMITH, DAVID RYAN, MILLER, ANDREW H · 2014 to 2025
$1.9M
NCATS NIH HHS UL1 TR001863NIMH NIH HHS R25 MH101079
6 · The paper itself

Abstract

objectivesRisperidone is approved for the treatment of serious behavioral problems in children with autism spectrum disorder (ASD). This study examined the effects of risperidone on cardiac conduction in children with ASD.

methodsData were collected from an 8-week, five-site trial conducted by the Research Units on Pediatric Psychopharmacology Autism Network. Children (age 5-17 years) were randomly assigned to risperidone (n = 49) or placebo (n = 52) under double-blind conditions. Risperidone was superior to placebo in reducing serious behavioral problems. A standard 12-lead, electrocardiogram (ECG) was obtained in most subjects at screening and week 8. A pediatric electrophysiologist blind to treatment assignment reviewed all available ECGs for readability, abnormalities, and cardiac conduction parameters, including QTc. The electrophysiologist measurements were compared to machine readings. A second blinded electrophysiologist examined all available ECGs for abnormalities and a 20% random sample for QTc.

resultsOf the 101 randomized subjects in the trial, complete pretreatment and week 8 data were available on 65 subjects (placebo n = 30; risperidone n = 35). The electrophysiologist did not identify any cardiac conduction adverse effects of risperidone and there was no difference in mean change on the QTc compared to placebo. The Bland-Altman plot showed a systematic bias in QTc measurements by the electrophysiologist and machine. Machine readings produced higher values than the electrophysiologist for shorter QTc intervals and machine scoring was lower than electrophysiologist readings for longer QTc values (p = 0.001). Two electrophysiologists had overall percent agreements of 82.9% (95% CI: 76.3 to 89.6) on qualitative assessment and 88.6% (95% CI: 79.3 to 98.0) on QTc interval.

conclusionUsing conventional doses during acute treatment in children with ASD and serious behavioral problems, there was no difference in the mean change in QTc between risperidone and placebo. Compared to the electrophysiologist, the machine readings may miss elevated QTc measurements.

Indexed as

ElectrocardiographyAdolescentAntipsychotic AgentsAutism Spectrum DisorderChildChild, PreschoolDouble-Blind MethodFemaleHumansMaleRisperidoneAntipsychotic AgentsRisperidoneautism spectrum disordercardiac conductionelectrocardiogramQTcrisperidone

Identifiers

PMID27726426
PMCPMC5178011
OpenAlexW2531301922

What OpenQuestion holds

Textmetadata
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.