1 40 1 Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Citation List Month Backlog URL Address <a href="http://doi.org/10.1056/NEJMoa013171" target="_blank" rel="noreferrer">http://doi.org/10.1056/NEJMoa013171</a> Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Risperidone in children with autism and serious behavioral problems Publisher An entity responsible for making the resource available The New England Journal Of Medicine Date A point or period of time associated with an event in the lifecycle of the resource 2002 Subject The topic of the resource 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 Creator An entity primarily responsible for making the resource 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 An account of the resource 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 An unambiguous reference to the resource within a given context <a href="http://doi.org/10.1056/NEJMoa013171" target="_blank" rel="noreferrer">10.1056/NEJMoa013171</a> Rights Information about rights held in and over the resource 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 The nature or genre of the resource 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