Evidence map›Paper›PMID 27126856›Full record

Trial reportJournal of the American Academy of Child and Adolescent Psychiatry2016

Weight Gain and Metabolic Consequences of Risperidone in Young Children With Autism Spectrum Disorder.

Lawrence Scahill, Sangchoon Jeon, Susan J Boorin, Christopher J McDougle, Michael G Aman, James Dziura, James T McCracken, Sonia Caprio, L Eugene Arnold, Ginger Nicol and 3 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Academy of Child and Adolescent Psychiatry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00080145 (Risperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder), which is not on this map. Cited by 36 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 5 pooled it
4.2field-weighted citation impact, top 6% 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.

NCT00080145 nacompletednot on this map

Risperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder

TypeinterventionalSponsorYale UniversityRan2004 to 2007Enrolled124ConditionsChild Development Disorders, PervasiveArmsRisperidone, Behavior Therapy
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 5 syntheses or guidelines pooled it, 83 citations in OpenAlex.

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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 at 7 institutions in 1 country.

Lawrence ScahillEmory University School of Medicine and Marcus Autism Center, Atlanta. Electronic address: lawrence.scahill@emory.edu.
Sangchoon JeonYale University School of Nursing, West Haven, CT.
Susan J BoorinYale University School of Nursing, West Haven, CT.
Christopher J McDougleHarvard Medical School, Massachusetts General Hospital, and Lurie Center for Autism, Boston.
Michael G AmanNisonger Center, Ohio State University, Columbus.
James DziuraYale School of Medicine, New Haven, CT.
James T McCrackenDivision of Child Psychiatry, University of California, Los Angeles.
Sonia CaprioYale School of Medicine, New Haven, CT.
L Eugene ArnoldNisonger Center, Ohio State University, Columbus.
Ginger NicolWashington University, St. Louis.
Yanhong DengYale University.
Saankari A ChallaEmory University School of Medicine.
Benedetto VitielloNational Institute of Mental Health (NIMH), Bethesda, MD.
Yale University · USEmory University · USThe Ohio State University Wexner Medical Center · USHarvard University · USNational Institute of Mental Health · USUniversity of California, Los Angeles · USWashington University in St. Louis · 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
Yale Pathology Tissue Services Shared ResourceP30CA016359 · NCI · YALE UNIVERSITY · PI DAVID L RIMM · 1985 to 2026
$85.0M
YALE UNIVERSITY CLINICAL AND TRANSLATIONAL SCIENCE AWARD PROGRAMUL1RR024139 · NCRR · YALE UNIVERSITY · PI SHERWIN, ROBERT S · 2006 to 2011
$56.8M
Yale Diabetes Research CenterP30DK045735 · NIDDK · YALE UNIVERSITY · PI Richard A Flavell · 1993 to 2026
$44.0M
University of Iowa Clinical and Translational Science Program (TL1)UL1RR025755 · NCRR · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2008 to 2011
$26.3M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
The Ohio State University Center for clinical and Translational ScienceUL1TR001070 · NCATS · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2013 to 2017
$22.6M
INDIANA CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE (UL1): BPCAUL1RR025761 · NCRR · INDIANA UNIVERSITY INDIANAPOLIS · PI SHEKHAR, ANANTHA · 2008 to 2011
$21.0M
RUPP-PIU10MH066766 · NIMH · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI MCDOUGLE, CHRISTOPHER J · 2002 to 2006
$2.7M
RUPP-PI Program at Yale UniversityU10MH066764 · NIMH · YALE UNIVERSITY · PI SCAHILL, LAWRENCE D. · 2002 to 2006
$2.5M
RUPP-PI ProjectU10MH066768 · NIMH · OHIO STATE UNIVERSITY · PI AMAN, MICHAEL GEORGE · 2002 to 2006
$2.4M
NCATS NIH HHS UL1 TR000454NCATS NIH HHS UL1 TR001070NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA016359NCRR NIH HHS UL1 RR024139NCRR NIH HHS UL1 RR025755NCRR NIH HHS UL1 RR025761NIDDK NIH HHS P30 DK045735NIMH NIH HHS U10 MH066764NIMH NIH HHS U10 MH066766NIMH NIH HHS U10 MH066768
6 · The paper itself

Abstract

objectiveWe examine weight gain and metabolic consequences of risperidone monotherapy in children with autism spectrum disorder (ASD).

methodThis was a 24-week, multisite, randomized trial of risperidone only versus risperidone plus parent training in 124 children (mean age 6.9 ± 2.35 years; 105 boys and 19 girls) with ASD and serious behavioral problems. We monitored height, weight, waist circumference, and adverse effects during the trial. Fasting blood samples were obtained before treatment and at week 16.

resultsIn 97 children with a mean of 22.9 ± 2.8 weeks of risperidone exposure, there was a 5.4 ± 3.4 kg weight gain over 24 weeks (p < .0001); waist circumference increased from 60.7 ± 10.4 cm to 66.8 ± 11.3 cm (p < .0001). At baseline, 59 of 97 children (60.8%) were classified as having normal weight; by week 24, only 25 of 85 (29.4%) remained in that group. Growth curve analysis showed a significant change in body mass index (BMI) z scores from pretreatment to week 24 (p < .0001). This effect was significantly greater for children with reported increased appetite in the first 8 weeks. From before treatment to week 16, there were significant increases in glucose (p = .02), hemoglobin A1c (p = .01), insulin (p <.0001), homeostatic model assessment-insulin resistance (HOMA-IR; p < .001), alanine aminotransferase (p = .01), and leptin (p < .0001). Adiponectin declined (p = .003). At baseline, 7 children met conventional criteria for metabolic syndrome; by week 16, 12 additional children were so classified.

conclusionRapid weight gain with risperidone treatment may promote the cascade of biochemical indices associated with insulin resistance and metabolic syndrome. Appetite, weight, waist circumference, liver function tests, blood lipids, and glucose warrant monitoring. Clinical trial registration information-Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders; http://clinicaltrials.gov/; NCT00080145.

Indexed as

Insulin ResistanceProblem BehaviorAntipsychotic AgentsAutism Spectrum DisorderChildChild, PreschoolFemaleHumansMaleMetabolic SyndromeRisperidoneWeight GainAntipsychotic AgentsRisperidoneautism spectrum disorderinsulin resistancemetabolic syndromerisperidoneweight gain

Identifiers

PMID27126856
PMCPMC4851735
OpenAlexW2293695912

What OpenQuestion holds

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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.