A 3-Year Naturalistic Study of 53 Preschool Children With Pervasive Developmental Disorders Treated With Risperidone
J Clin Psychiatry 2003;64:1039-1047
© Copyright 2014 Physicians Postgraduate Press, Inc.
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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
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 53])
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