Second Atypical Is Approved for Treating Schizophrenia in Teens

By Mechcatie, Elizabeth | Clinical Psychiatry News, December 2007 | Go to article overview

Second Atypical Is Approved for Treating Schizophrenia in Teens


Mechcatie, Elizabeth, Clinical Psychiatry News


The Food and Drug Administration has approved aripiprazole for the treatment of schizophrenia in adolescents.

The approval, which came in late October and is based on a 6-week study of 302 adolescents in 13 countries, makes aripiprazole (Abilify) the second atypical antipsychotic approved for adolescents.

In August, risperidone (Risperdal) was approved for treating schizophrenia in adolescents aged 13-17 years, as well as for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder in children and adolescents aged 10-17 years. Previously, risperidone was approved for irritability associated with autism.

And another atypical antipsychotic currently is under review for treatment in adolescents. The FDA is looking at olanzapine (Zyprexa) for treating schizophrenia and bipolar disorder in adolescents aged 13-17, and the drug is considered "approvable" for those two indications. (On Nov. 15, Bristol-Myers Squibb Co. announced that the company had submitted an application for the approval of aripiprazole for treating bipolar I disorder, manic or mixed episode with or without psychotic features, in patients aged 10-17 years).

Dr. David Fassler, a child and adolescent psychiatrist in Burlington, Vt., said he was pleased to see more medications approved specifically for treating child and adolescent psychiatric disorders. "We're well aware that children are not just little adults when it comes to medication," said Dr. Fassler of the University of Vermont, Burlington. "We can't just extrapolate from research and clinical experience involving older patients."

Despite these approvals, all atypical antipsychotics, including aripiprazole, should be used with caution in pediatric populations, Dr. Fassler said. He also pointed out that the aripiprazole approval was based on relatively short-term trials. "Parents and physicians need outcome data from long-term studies of both safety and efficacy in order to make fully informed decisions about treatment options," he said.

Aripiprazole, a dopamine partial agonist marketed by Bristol-Myers Squibb and manufactured by Otsuka Pharmaceutical Co., is approved in adults for acute and maintenance treatment of both schizophrenia and bipolar disorder with or without psychotic features. …

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