Use of Risperidone in Children With Autism, Bipolar Disease, or Schizophrenia

Marcia L. Buck, Pharm.D., FCCP

Pediatr Pharm. 2008;14(1) 

In This Article

Clinical Studies in Children

Since the initial approval of risperidone by the FDA in 1993, several hundred papers have been published describing its use in children and adolescents. They range from isolated case reports to well-designed multicenter controlled clinical trials, and address use not only in autism, bipolar disorder, and schizophrenia, but also in Tourette's syndrome, tic disorders, oppositional defiant disorder, conduct disorder, anorexia nervosa, and other conditions.

Two recent studies highlight its benefits in children with autism.[4,5] In 2002, McCracken and colleagues, representing the Research Units on Pediatric Psychopharmacology (RUPP) Autism Network, published the results of their multicenter risperidone trial in The New England Journal of Medicine.[4] A total of 101 children (5-12 years of age) with autism were randomized to receive either risperidone (0.5 to 3.5 mg/day) or placebo. Primary outcome measures were scores on the irritability subscale of the Aberrant Behavior Checklist (ABC) and scores on the Clinical Global Impressions-Improvement (CGI-I) scale.

At 8 weeks, the risperidone group had a 56.9% reduction in their irritability subscale score, compared to only a 14.1% reduction in the placebo group (p<0.001). The rate of an overall positive response, defined as at least a 25% decrease in the irritability score and a rating of much improved or very much improved on the CGI-I scale, was 69% in the risperidone group, compared to 12% in the controls (p<0.001). Two-thirds of the patients with a positive response to risperidone maintained that benefit at 6 months.[4]

Shea and colleagues conducted an 8-week controlled study in 79 children (5-12 years) with autism or pervasive developmental disorders.[5] The children were randomized to receive risperidone (0.1 mg/kg/day titrated up to 0.6 mg/kg/day) or placebo. Symptoms were assessed using the irritability score on the ABC, the Nisonger Child Behavior Rating Form, and the CGI-Change scale (CGI-C). The risperidonetreated patients had a significantly greater decrease in their irritability score compared to placebo (64% versus 31%). The treatment group also had a greater degree of improvement in their remaining ABC scores and the Nisonger form. Eighty-seven percent of the risperidone patients had improvement of their CGI-C scores, compared to only 40% in the placebo group. More children in the risperidone group experienced adverse effects, but most were mild and responded to dosage adjustment. Weight gain was higher in the risperidone group (2.7 kg versus 1 kg). There were no differences in extrapyramidal symptoms between the groups.[5]

The efficacy of risperidone in adolescents with newly-diagnosed schizophrenia was assessed by Zalsman and coworkers in an open-label 6 week trial.[6] Eleven patients (15-20 years of age) were assessed with the Positive and Negative Syndrome Scale (PANSS), the Brief Psychiatric Rating Scale (BPRS), and the CGI-Severity scale. The average dose of risperidone was 3.14±1.60 mg/day. The average improvement in PANSS score was 28%, BPRS was 30.11%, and CGI-Severity score was 31.36% (all p<0.01 compared to baseline). Negative signs were not significantly improved. Adverse reactions included extrapyramidal effects, somnolence, depression, and weight gain.

Biederman and colleagues recently evaluated risperidone in 30 children (ages 6-17 years) with manic, mixed, or hypomanic bipolar disorder.[7] In this 8-week open-label study, 70% of the children achieved a CGI-I score ≤ 2. The average dose was 1.25±1.5 mg/day. Adverse effects included a four-fold increase in serum prolactin levels and an average weight gain of 2.1±2.0 kg.

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