Evidence map›Paper›PMID 24350813›Full record

Trial reportJournal of child and adolescent psychopharmacology2013

An open-label extension study of the safety and efficacy of risperidone in children and adolescents with autistic disorder.

Justine M Kent, David Hough, Jaskaran Singh, Keith Karcher, Gahan Pandina

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of child and adolescent psychopharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00576732 (Risperidone in the Treatment of Children and Adolescents With Autistic Disorder), which is not on this map. Cited by 17 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 4 pooled it
0.8field-weighted citation impact, top 30% 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.

NCT00576732 phase4completednot on this map

Risperidone in the Treatment of Children and Adolescents With Autistic Disorder: A Double-Blind, Placebo-Controlled Study of Efficacy and Safety, Followed by an Open-Label Extension Study of Safety

TypeinterventionalSponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Ran2007 to 2010Enrolled96ConditionsAutistic Disorder, AutismArmsPlacebo, Risperidone high dose, Risperidone low dose
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 4 syntheses or guidelines pooled it, 59 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

5 authors at 1 institution in 1 country.

Justine M KentJanssen Research & Development , LLC, Titusville, New Jersey.
David Hough
Jaskaran Singh
Keith Karcher
Gahan Pandina
Janssen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe purpose of this study was to evaluate the long-term safety and efficacy of risperidone in treating irritability and related behaviors in children and adolescents with autistic disorders.

methodsIn this 6 month (26 week) open-label extension (OLE) study, patients (5-17 years of age, who completed the previous fixed-dose, 6 week, double-blind [DB] phase) were flexibly dosed with risperidone based on body weight. The maximum allowed dose was 1.25 mg/day for those weighing 20 to <45 kg, and 1.75 mg/day for those weighing ≥ 45 kg. The study primarily assessed risperidone's safety; efficacy was assessed as a secondary end-point.

resultsFifty-six (71%) out of 79 enrolled patients completed the OLE; the most common discontinuations were for insufficient response (7 [9%]) or adverse events (AE) (5 [6%]). The most common (≥ 5% frequency in the total group) AEs were increased appetite (11% [n=9]); increased weight and vomiting (9% [n=7] each); sedation, pyrexia, and upper respiratory tract infection (8% [n=6] each); nasopharyngitis (6% [n=5]); and somnolence and fatigue (5% [n=4] each). Extrapyramidal AEs were reported in 6 (8%) patients. Increase in mean weight (11-15%) and body mass index (5-10%) occurred; one patient discontinued because of weight increase. One potentially prolactin-related AE (irregular menstruation) was reported. The risperidone high-dose group had the greatest mean improvement in sleep visual analog scale (24.6). All groups showed additional improvement in efficacy scale scores during the OLE.

conclusionsDuring this OLE, safety findings with risperidone treatment (maximum weight-based dose of 1.25 mg/day or 1.75 mg/day) were consistent with those observed in the DB phase, and with the current safety information for risperidone in autistic, psychiatric, and behavioral disorders. Patients experienced some additional improvement in irritability and related behaviors. CLINICAL TRIALS REGISTRY: This phase-4 study is registered at ClinicalTrials.gov (NCT00576732).

Indexed as

AdolescentAntipsychotic AgentsAutistic DisorderBody Mass IndexChildChild, PreschoolDouble-Blind MethodFemaleHumansMaleRisperidoneAntipsychotic AgentsRisperidone

Identifiers

PMID24350813
PMCPMC3870601
OpenAlexW1995736470

What OpenQuestion holds

Textmetadata
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.