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Text
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<a href="http://doi.org/10.1056/NEJMoa013171" target="_blank" rel="noreferrer">http://doi.org/10.1056/NEJMoa013171</a>
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Title
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Risperidone in children with autism and serious behavioral problems
Publisher
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The New England Journal Of Medicine
Date
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2002
Subject
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Child; Female; Humans; Male; Treatment Outcome; Double-Blind Method; adolescent; Preschool; Non-U.S. Gov't; P.H.S.; Research Support; U.S. Gov't; Comparative Study; Antipsychotic Agents/administration & dosage/adverse effects/therapeutic use; Autistic Disorder/drug therapy/psychology; Child Behavior/drug effects; Risperidone/administration & dosage/adverse effects/therapeutic use
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McCracken JT; McGough J; Shah B; Cronin P; Hong D; Aman MG; Arnold LE; Lindsay R; Nash P; Hollway J; McDougle CJ; Posey D; Swiezy N; Kohn A; Scahill L; Martin A; Koenig K; Volkmar F; Carroll D; Lancor A; Tierney E; Ghuman J; Gonzalez NM; Grados M; Vitiello B; Ritz L; Davies M; Robinson J; McMahon D; Research Units on Pediatric Psychopharmacology (RUPP) Autism Network
Description
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BACKGROUND: Atypical antipsychotic agents, which block postsynaptic dopamine and serotonin receptors, have advantages over traditional antipsychotic medications in the treatment of adults with schizophrenia and may be beneficial in children with autistic disorder who have serious behavioral disturbances. However, data on the safety and efficacy of atypical antipsychotic agents in children are limited. METHODS: We conducted a multisite, randomized, double-blind trial of risperidone as compared with placebo for the treatment of autistic disorder accompanied by severe tantrums, aggression, or self-injurious behavior in children 5 to 17 years old. The primary outcome measures were the score on the Irritability subscale of the Aberrant Behavior Checklist and the rating on the Clinical Global Impressions - Improvement (CGI-I) scale at eight weeks. RESULTS: A total of 101 children (82 boys and 19 girls; mean [+/-SD] age, 8.8+/-2.7 years) were randomly assigned to receive risperidone (49 children) or placebo (52). Treatment with risperidone for eight weeks (dose range, 0.5 to 3.5 mg per day) resulted in a 56.9 percent reduction in the Irritability score, as compared with a 14.1 percent decrease in the placebo group (P<0.001). The rate of a positive response, defined as at least a 25 percent decrease in the Irritability score and a rating of much improved or very much improved on the CGI-I scale, was 69 percent in the risperidone group (34 of 49 children had a positive response) and 12 percent in the placebo group (6 of 52, P<0.001). Risperidone therapy was associated with an average weight gain of 2.7+/-2.9 kg, as compared with 0.8+/-2.2 kg with placebo (P<0.001). Increased appetite, fatigue, drowsiness, dizziness, and drooling were more common in the risperidone group than in the placebo group (P<0.05 for each comparison). In two thirds of the children with a positive response to risperidone at eight weeks (23 of 34), the benefit was maintained at six months. CONCLUSIONS: Risperidone was effective and well tolerated for the treatment of tantrums, aggression, or self-injurious behavior in children with autistic disorder. The short period of this trial limits inferences about adverse effects such as tardive dyskinesia.
2002
Identifier
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<a href="http://doi.org/10.1056/NEJMoa013171" target="_blank" rel="noreferrer">10.1056/NEJMoa013171</a>
Rights
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Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
Type
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Journal Article
2002
Adolescent
Aman MG
Antipsychotic Agents/administration & dosage/adverse effects/therapeutic use
Arnold LE
Autistic Disorder/drug therapy/psychology
Backlog
Carroll D
Child
Child Behavior/drug effects
Comparative Study
Cronin P
Davies M
Double-Blind Method
Female
Ghuman J
Gonzalez NM
Grados M
Hollway J
Hong D
Humans
Journal Article
Koenig K
Kohn A
Lancor A
Lindsay R
Male
Martin A
McCracken JT
McDougle CJ
McGough J
McMahon D
Nash P
Non-U.S. Gov't
P.H.S.
Posey D
Preschool
Research Support
Research Units on Pediatric Psychopharmacology (RUPP) Autism Network
Risperidone/administration & dosage/adverse effects/therapeutic use
Ritz L
Robinson J
Scahill L
Shah B
Swiezy N
The New England Journal Of Medicine
Tierney E
Treatment Outcome
U.S. Gov't
Vitiello B
Volkmar F