Risperidone in Children with Autism and Serious Behavioral Problems
Top Cited Papers
- 1 August 2002
- journal article
- clinical trial
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 347 (5), 314-321
- https://doi.org/10.1056/nejmoa013171
Abstract
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. 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. 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. 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.This publication has 23 references indexed in Scilit:
- Methodological Issues in Designing a Multisite Trial of Risperidone in Children and Adolescents with AutismJournal of Child and Adolescent Psychopharmacology, 2001
- Does Fast Dissociation From the Dopamine D2Receptor Explain the Action of Atypical Antipsychotics?: A New HypothesisAmerican Journal of Psychiatry, 2001
- Neuroleptic-Related Dyskinesias in Autistic Children: A Prospective, Longitudinal StudyJournal of the American Academy of Child & Adolescent Psychiatry, 1997
- Risperidone Treatment of Children and Adolescents With Pervasive Developmental Disorders: A Prospective, Open-Label StudyJournal of the American Academy of Child & Adolescent Psychiatry, 1997
- Use of Risperidone in Pervasive Developmental Disorders: A Case SeriesJournal of Child and Adolescent Psychopharmacology, 1996
- Some Conceptual and Statistical Issues in Analysis of Longitudinal Psychiatric DataArchives of General Psychiatry, 1993
- Factor validity and norms for the Aberrant Behavior Checklist in a community sample of children with mental retardationJournal of Autism and Developmental Disorders, 1992
- Prevalence of infantile autism in four French regionsSocial psychiatry. Sozialpsychiatrie. Psychiatrie sociale, 1992
- The effects of haloperidol on discrimination learning and behavioral symptoms in autistic childrenJournal of Autism and Developmental Disorders, 1989
- A RATING SCALE FOR EXTRAPYRAMIDAL SIDE EFFECTSActa Psychiatrica Scandinavica, 1970