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Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders.
Pediatrics. 2004 Nov; 114(5):e634-41.Ped

Abstract

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.

Authors+Show Affiliations

IWK Health Centre, and Dalhousie University, Halifax, Nova Scotia, Canada. sarah.shea@iwk.nshealth.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15492353

Citation

Shea, Sarah, et al. "Risperidone in the Treatment of Disruptive Behavioral Symptoms in Children With Autistic and Other Pervasive Developmental Disorders." Pediatrics, vol. 114, no. 5, 2004, pp. e634-41.
Shea S, Turgay A, Carroll A, et al. Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders. Pediatrics. 2004;114(5):e634-41.
Shea, S., Turgay, A., Carroll, A., Schulz, M., Orlik, H., Smith, I., & Dunbar, F. (2004). Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders. Pediatrics, 114(5), e634-41.
Shea S, et al. Risperidone in the Treatment of Disruptive Behavioral Symptoms in Children With Autistic and Other Pervasive Developmental Disorders. Pediatrics. 2004;114(5):e634-41. PubMed PMID: 15492353.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders. AU - Shea,Sarah, AU - Turgay,Atilla, AU - Carroll,Alan, AU - Schulz,Miklos, AU - Orlik,Herbert, AU - Smith,Isabel, AU - Dunbar,Fiona, Y1 - 2004/10/18/ PY - 2004/10/20/pubmed PY - 2005/3/11/medline PY - 2004/10/20/entrez SP - e634 EP - 41 JF - Pediatrics JO - Pediatrics VL - 114 IS - 5 N2 - 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. SN - 1098-4275 UR - https://www.unboundmedicine.com/medline/citation/15492353/Risperidone_in_the_treatment_of_disruptive_behavioral_symptoms_in_children_with_autistic_and_other_pervasive_developmental_disorders_ L2 - http://pediatrics.aappublications.org/cgi/pmidlookup?view=long&pmid=15492353 DB - PRIME DP - Unbound Medicine ER -