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Risperidone monotherapy in preschool children with pervasive developmental disorders
1Division of Child Neurology and Psychiatry, University of Pisa, Italy. masi@.inpe.unipi.it
Journal of Child Neurology
|June 22, 2001
Summary
This preliminary study found that risperidone showed modest short-term efficacy and safety in preschool children with autism spectrum disorder (ASD). Side effects were generally mild, with most participants showing improvement in core symptoms.
Area of Science:
- Child and Adolescent Psychiatry
- Developmental Neuroscience
- Pharmacology
Background:
- Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition affecting social interaction and communication.
- Limited pharmacological options exist for managing core symptoms in preschool-aged children with ASD.
- Atypical antipsychotics are sometimes used off-label, necessitating efficacy and safety data in this population.
Purpose of the Study:
- To evaluate the short-term efficacy and safety of risperidone monotherapy in preschool children diagnosed with ASD.
- To assess the impact of risperidone on core autism symptoms and overall functioning.
- To identify potential side effects associated with risperidone treatment in this age group.
Main Methods:
- A 16-week, open-label trial involving 10 preschool children (mean age 4.7 years) with ASD.
- Risperidone administered as monotherapy, starting at 0.25 mg/day and titrated up to a maximum of 0.50 mg/day (0.027 mg/kg/day).
- Outcome measures included the Childhood Autism Rating Scale (CARS), Children's Psychiatric Rating Scale (CPRS), Clinical Global Impression (CGI), and Children's Global Assessment of Functioning (CGAF).
Main Results:
- Eight of ten subjects completed the 16-week trial; two withdrew due to side effects (tachycardia, flushes, fever, hyporexia).
- Modest improvements observed in CARS, CPRS, and CGAF scores among completers.
- Four subjects showed significant improvement (much improved/very much improved) on CGI, while four showed minimal improvement.
- No behavioral deterioration was noted, and side effects in completers were not severe.
Conclusions:
- Risperidone appears to offer modest short-term benefits for core symptoms and functioning in preschool children with ASD.
- The safety profile in this preliminary study was acceptable, with manageable side effects.
- Further research with larger, placebo-controlled trials is warranted to confirm these findings.