Long-term effects of risperidone in children with autism spectrum disorders: a placebo discontinuation study

Area of Science:

• Child and Adolescent Psychiatry
• Neurodevelopmental Disorders
• Pharmacological Interventions

Background:

• Short-term efficacy of risperidone for severe disruptive behaviors in pediatric autism spectrum disorder (ASD) is known.
• Limited long-term placebo-controlled data exist for risperidone's efficacy in ASD.

Purpose of the Study:

• To evaluate the long-term effectiveness of risperidone in managing severe disruptive behaviors in children with ASD.
• To assess the efficacy of continuing risperidone treatment versus placebo in preventing relapse.

Main Methods:

• Open-label risperidone treatment for 8 weeks in 36 children (5-17 years) with ASD and severe disruptive behaviors.
• Responders (n=26) entered a 16-week continuation phase, followed by a double-blind discontinuation phase (n=24) comparing risperidone to placebo.
• Relapse was defined by clinical judgment and parent questionnaire indicating significant symptom deterioration.

Main Results:

• Risperidone was significantly more effective than placebo in preventing relapse (3/12 vs. 8/12 patients, p = .049).
• Common side effects included weight gain, increased appetite, anxiety, and fatigue.
• Approximately half of the children with ASD experienced reduced disruptive behavior with risperidone treatment.

Conclusions:

• This study supports the effectiveness of risperidone for several months in reducing disruptive behavior in pediatric ASD.
• Continuing risperidone beyond 6 months is justified, but significant weight gain may limit its long-term use.
• Further research may explore strategies to mitigate weight gain associated with risperidone therapy.