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/10.1542/peds.2003-0264-F" target="_blank" rel="noreferrer">http://doi.org/10.1542/peds.2003-0264-F</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 the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders Publisher An entity responsible for making the resource available Pediatrics Date A point or period of time associated with an event in the lifecycle of the resource 2004 Subject The topic of the resource Child; Female; Humans; Male; Treatment Outcome; Double-Blind Method; Preschool; Child Development Disorders; Autistic Disorder/drug therapy; Dopamine Antagonists/therapeutic use; Serotonin Antagonists/therapeutic use; Aggression/drug effects; Antipsychotic Agents/adverse effects/pharmacology/therapeutic use; Irritable Mood/drug effects; Pervasive/drug therapy; Risperidone/adverse effects/pharmacology/therapeutic use Creator An entity primarily responsible for making the resource Shea S; Turgay A; Carroll A; Schulz M; Orlik H; Smith I; Dunbar F Description An account of the resource OBJECTIVE: To investigate the efficacy and safety of risperidone for the treatment of disruptive behavioral symptoms in children with autism and other pervasive developmental disorders (PDD). METHODS: In this 8-week, randomized, double-blind, placebo-controlled trial, risperidone/placebo solution (0.01-0.06 mg/kg/day) was administered to 79 children who were aged 5 to 12 years and had PDD. Behavioral symptoms were assessed using the Aberrant Behavior Checklist (ABC), Nisonger Child Behavior Rating Form, and Clinical Global Impression-Change. Safety assessments included vital signs, electrocardiogram, extrapyramidal symptoms, adverse events, and laboratory tests. RESULTS: Subjects who were taking risperidone (mean dosage: 0.04 mg/kg/day; 1.17 mg/day) experienced a significantly greater mean decrease on the irritability subscale of the ABC (primary endpoint) compared with those who were taking placebo. By study endpoint, risperidone-treated subjects exhibited a 64% improvement over baseline in the irritability score almost double that of placebo-treated subjects (31%). Risperidone-treated subjects also exhibited significantly greater decreases on the other 4 subscales of the ABC; on the conduct problem, insecure/anxious, hyperactive, and overly sensitive subscales of the Nisonger Child Behavior Rating Form (parent version); and on the Visual Analog Scale of the most troublesome symptom. More risperidone-treated subjects (87%) showed global improvement in their condition compared with the placebo group (40%). Somnolence, the most frequently reported adverse event, was noted in 72.5% versus 7.7% of subjects (risperidone vs placebo) and seemed manageable with dose/dose-schedule modification. Risperidone-treated subjects experienced statistically significantly greater increases in weight (2.7 vs 1.0 kg), pulse rate, and systolic blood pressure. Extrapyramidal symptoms scores were comparable between groups. CONCLUSIONS: Risperidone was well tolerated and efficacious in treating behavioral symptoms associated with PDD in children. 2004 Identifier An unambiguous reference to the resource within a given context <a href="http://doi.org/10.1542/peds.2003-0264-F" target="_blank" rel="noreferrer">10.1542/peds.2003-0264-F</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 2004 Aggression/drug effects Antipsychotic Agents/adverse effects/pharmacology/therapeutic use Autistic Disorder/drug therapy Backlog Carroll A Child Child Development Disorders Dopamine Antagonists/therapeutic use Double-Blind Method Dunbar F Female Humans Irritable Mood/drug effects Journal Article Male Orlik H Pediatrics Pervasive/drug therapy Preschool Risperidone/adverse effects/pharmacology/therapeutic use Schulz M Serotonin Antagonists/therapeutic use Shea S Smith I Treatment Outcome Turgay A