Until now, only lithium was approved for the treatment of bipolar disorder in adolescents ages 12 and up and no drug could be used for pediatric schizophrenia. The U.S. Food and Drug Administration approved Risperdal (active substance: risperidone), an atypical antipsychotic medication made by Janssen, L.P. of Titusville, N.J., for children and teens aged 10 to 17 who have both disorders.

“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 the director of FDA’s Office of Pediatric Therapeutics, Dianne Murphy. “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 was previously approved for the treatment of irritability associated with autistic disorder in children and adolescents 5 to 16 years old, according to the U.S. Food and Drug Administration. The FDA had requested Janssen to carry out the studies that led to the pediatric approval because some doctors already used it to treat kids, even though it was an off-label use.

Janssen carried two short-term (6 to 8 weeks), double-blind, controlled trials for schizophrenia, which showed patients generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of their illness, according to FDA's press release. A three-week, randomized, double-blind, placebo-controlled, multicenter trial was carried out to determine the effectiveness in bipolar I disorder, which yielded similar results.

Risperidone is available as a tablet, ampoule (Risperdal Consta, which is a depot injection administered once every two weeks) and as a wafer (Risperdal Quicklets).