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| |  AACAP: Risperidone (Risperdal) Beneficial in Children Pervasive Developmental Disorder By Paula Moyer Special to DG News SAN FRANCISCO, CA -- October 286, 2002 -- The atypical antipsychotic risperidone (Risperdal) is effective at addressing the behavioural symptoms exhibited by children with pervasive developmental disorders (PDD), according to Dr. Sarah E. Shea. "We found risperidone to be significantly helpful for addressing a variety of difficult behavioural symptoms associated with PDD," said Dr. Shea. "Key among these were behaviours associated with irritability, such as self-abuse, tantrums, and aggression." Dr. Shea is an associate professor of psychiatry at Dalhousie University in Halifax, Nova Scotia, Canada, where she is the director of the Isaak Walton Killan Grace Health Centre. In a study presented here at the 49th annual meeting of the American Academy of Child and Adolescent Psychiatry, she and colleagues followed 79 children with PDD in an 8-week study. The children were randomised to either treatment or placebo in a double-blind, placebo-controlled trial. Among the subjects, 56 had autistic disorder, one had childhood disintegrative disorder, 12 had Asberger's disorder, and 11 had PDD not otherwise specified. The children ranged in age from five to 12 years old. The risperidone dose ranged from 0.01 to 0.06 mg/kg/day, with an average dose of 0.04 mg/kg/day. The investigators assessed the subject behavioural symptoms with the Aberrant Behaviour Checklist (ABC), the Nisonger Child Behaviour Rating form (N-CBRF) and the Clinical Global Impression scale (CGI). They assessed medication safety by vital signs, electrocardiogram, documentation of extrapyramidal symptoms (EPS), incidence of adverse events, and laboratory tests. At the study’s end, the children in the risperidone arm had a significant decrease on the ABC irritability subscale (p<0.001) as well as other ABC subscales (p<0.05) and the N-CBRF Conduct Problem subscale (p<0.01), in contrast to those in the placebo arm. The treatment group also had an 85 percent improvement in the CGI, while the placebo group's CGI improved a mean of 42 percent. The most frequently reported adverse event was somnolence, which was experienced by 72.5 percent of treatment subjects and 10.3 percent of placebo subjects. This effect can be managed by modifying either the dose or the dose schedule, Dr. Shea said, such as bedtime dosing or split dosing. Other common adverse events, experienced by more than 20 percent of subjects in the risperidone group, include upper respiratory infection, rhinitis, increased appetite, and abdominal pain. The children in the risperidone group gained a mean of 2.7 ± 2.0 kg, compared to a mean of 1.0 ± 1.6 kg in the placebo group (p<0.001). Ten subjects in the treatment group and four subjects in the placebo group developed EPS. This difference was not statistically significant, Dr. Shea said. On the basis of the study's findings, she and colleagues began to treat all the children with risperidone, she concluded.
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