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Open Trial of Risperidone in 24 Young Children With Pervasive Developmental Disorders

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ABSTRACT

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.

Section snippets

Subjects

All children aged between 3 and 6.11 years referred to our Division of Child Neurology and Psychiatry as inpatients or outpatients during 1999 and 2000 were screened for psychiatric disorders; historical information, clinical interviews, and symptom ratings according to DSM-IV criteria (American Psychiatric Association, 1994) were used. Our clinic is a university research hospital with a national catchment for children and adolescents with a wide range of neuropsychiatric disorders. The

RESULTS

Two subjects did not complete the study, as parents requested discontinuation of the treatment because of side effects. After 2 weeks of treatment one child experienced marked sedation and hyporexia. Before discontinuing treatment, the child's parents had reported an improvement in self-injurious behaviors, which worsened again when the medication was interrupted. The parents of the other child decided to discontinue risperidone after 7 days of treatment (dosage 0.25 mg/day) because of episodes

DISCUSSION

The aim of this study was to assess the efficacy and safety of risperidone monotherapy in children with PDD. The age range (3.6–6.6 years) and mean age (4.6 ± 0.8 years) of these patients is significantly lower than in previous case series. Rating scales including multiple items were used in this study (CPRS and CARS), and both total score and individual item scores were considered. Although multiple statistical analyses, in the search for the treatment effect, required “a high statistical

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