Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders

Pediatrics. 2004 Nov;114(5):e634-41. doi: 10.1542/peds.2003-0264-F. Epub 2004 Oct 18.


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.

Publication types

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

MeSH terms

  • Aggression / drug effects
  • Antipsychotic Agents / adverse effects
  • Antipsychotic Agents / pharmacology
  • Antipsychotic Agents / therapeutic use*
  • Autistic Disorder / drug therapy
  • Child
  • Child Development Disorders, Pervasive / drug therapy*
  • Child, Preschool
  • Dopamine Antagonists / therapeutic use
  • Double-Blind Method
  • Female
  • Humans
  • Irritable Mood / drug effects
  • Male
  • Risperidone / adverse effects
  • Risperidone / pharmacology
  • Risperidone / therapeutic use*
  • Serotonin Antagonists / therapeutic use
  • Treatment Outcome


  • Antipsychotic Agents
  • Dopamine Antagonists
  • Serotonin Antagonists
  • Risperidone