THURSDAY, Aug. 23 (HealthDay News) -- The U.S. Food and Drug Administration has approved Risperdal (risperidone) to treat children and adolescents with two major psychiatric conditions. A short-term course can now be prescribed to treat manic or mixed episodes of bipolar I disorder in children and adolescents aged 10 to 17, and can also be used to treat adolescents aged 13 to 17 with schizophrenia.
Approval was granted on the basis of two short-term, double-blind, placebo-controlled studies of adolescents with schizophrenia who had an acute episode of schizophrenia prior to enrollment, which showed that a six- to eight-week course of treatment reduced symptoms. A three-week randomized, double-blind, placebo-controlled trial showed that Risperdal was effective in reducing symptoms during a manic or mixed episode in patients with bipolar I disorder.
"The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose and safety of using this product in the pediatric population," said Dianne Murphy, M.D., director of FDA's Office of Pediatric Therapies, in a statement. "These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients."
Risperdal, manufactured by Janssen. L.P., of Titusville, N.J., has already gained approval to treat bipolar I disorder in adults and autistic disorder in children and adolescents aged 5 to 16 years old.
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