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Open trial of risperidone in 24 young children with pervasive developmental disorders
1Division of Child Neurology and Psychiatry, University of Pisa, and IRCCS Stella Maris, Calambrone, Italy. masi@inpe.unipi.it
Insights
Low-dose risperidone effectively treated young children with pervasive developmental disorders, improving behavior and emotional regulation. This medication showed good tolerability and efficacy in a 16-week trial.
Area of Science:
- Child and Adolescent Psychiatry
- Developmental Neuroscience
- Pharmacology
Background:
- Pervasive Developmental Disorders (PDDs) present significant challenges in young children.
- Limited treatment options exist for very young children with PDDs.
- Risperidone is an atypical antipsychotic used for behavioral symptoms in older populations.
Purpose of the Study:
- To evaluate the tolerability and efficacy of risperidone monotherapy in children aged 3.6 to 6.6 years with PDDs.
- To identify optimal dosing and assess symptom improvement.
- To determine the safety profile of risperidone in this age group.
Main Methods:
- An open-label, 16-week trial involving 24 children with PDDs.
- Administered risperidone monotherapy with dose optimization.
- Utilized standardized rating scales: Children's Psychiatric Rating Scale (CPRS), Childhood Autism Rating Scale (CARS), Clinical Global Impression-Improvement (CGI-I), and Children's Global Assessment Scale (C-GAS).
Main Results:
- Optimal dose determined to be 0.5 mg/day.
- Significant improvements observed: 21% in CPRS, 14% in CARS.
- Behavioral control and affect regulation improved by over 25%.
- 54% of subjects experienced no side effects; risperidone was generally well tolerated.
- Functional impairment (C-GAS) improved by over 25%.
Conclusions:
- Low-dose risperidone shows promise for improving disruptive behavior and affective dysregulation in young autistic children.
- The medication is generally well-tolerated in this population.
- Further controlled studies are recommended to confirm efficacy and safety in this age group.
Objective:
To describe tolerability and efficacy of risperidone in very young children with pervasive developmental disorders.
Method:
Twenty-four children aged 3.6 to 6.6 years (mean 4.6 years +/- 8 months) enrolled during 1999 and 2000 participated in a 16-week open-label trial with risperidone monotherapy. Outcome measures included the Children's Psychiatric Rating Scale (CPRS), Childhood Autism Rating Scale (CARS), Clinical Global Impression-Improvement (CGI-I), and Children's Global Assessment Scale (C-GAS).
Results:
Two subjects did not complete the trial because of side effects. The optimal dose was 0.5 mg/day. After the treatment a 21% improvement in CPRS and a 14% improvement in CARS total scores was found. Items related to behavioral control (hyperactivity, fidgetiness, rhythmic motions) and affect regulation (lability of affect, angry affect) improved more than 25%. Based on improvement of at least 25% on the CPRS and a score of 1 or 2 on the CGI-I, eight subjects were considered responders. Functional impairment (C-GAS) improved more than 25%. Thirteen subjects (54%) were free of any side effects; in the other participants risperidone was well tolerated. Only three subjects had a weight gain greater than 10%.
Conclusions:
Low-dose risperidone may positively affect symptoms in young autistic children, improving disruptive/hyperactive behavior and affective dysregulation. Further controlled studies in this age group are warranted.