Aripiprazole Well Tolerated in Pediatric Bipolar Disorder, Schizophrenia

Paula Moyer, MA

October 25, 2005

Oct. 25, 2005 (Toronto) — Children and adolescents with schizophrenia, bipolar disorder, and other severe psychiatric diagnoses improved significantly when treated with aripiprazole (Abilify) and tolerated it well across several doses, according to investigators who presented their findings here at a joint meeting of the American and Canadian Academies of Child and Adolescent Psychiatry.

Although aripiprazole has been approved to treat schizophrenia and bipolar disorder in adults, it has not yet been approved for use in children and adolescents. Principal investigator Robert L. Findling, MD, said that he and his coinvestigators wanted to see whether aripiprazole would be an appropriate treatment option in children with such severe conditions because other atypical antipsychotics have been shown to be beneficial in this population. Dr. Findling is a professor of psychiatry and pediatrics at Case Western Reserve University in Cleveland, Ohio, where he is the director of child and adolescent psychiatry at the University Hospitals of Cleveland.

"This study provides support for the exploration of the entire adult dose range of aripiprazole in schizophrenia and bipolar disorder," Dr. Findling said, noting that investigators are currently conducting clinical trials on aripiprazole in children and adolescents with such diagnoses.

Using aripiprazole to treat severe mental illnesses in children and adolescents represents one of the latest developments in the quest for a more benign antipsychotic. The atypical antipsychotics do not cause the extrapyramidal symptoms (EPS) that are the hallmark of older "typical" antipsychotics, but the newer drugs are often associated with metabolic adverse effects such as weight gain and lipid dysregulation. Aripiprazole is unique in this drug class in that it apparently is not linked to these effects.

The Food and Drug Administration (FDA) requested that the investigators study the tolerability of aripiprazole in children and adolescents at three doses. Therefore, Dr. Findling and his coinvestigators recruited 19 patients with schizophrenia, schizenophreniform, and bipolar disorder who were 10 to 17 years old, and studied their ability to tolerate aripiprazole at doses often used to treat adults. The patients were started at doses of 2 mg daily and then increased to 5 mg daily and then continued to increase in increments of 5 mg until they reached one of the following dose levels: 20 mg, 25 mg, or 30 mg. The patients then continued to take the medication at the target doses for an additional 14 days.

Among these patients, 17 (89%) were either "improved" or "much improved," according to physicians who assessed them with the Clinical Global Impression (CGI) Improvement score. The baseline average CGI-Severity score was 3.7, or moderately mentally ill; the score at the end of the study was 1.9, or "borderline" mentally ill.

The investigators assessed the medication's safety with the spontaneous reporting of adverse events, electrocardiography, vital signs, clinical laboratory tests, a physical examination, and the EPS rating scales, including the Simpson-Angus scale, the Abnormal Involuntary Movement scale, and the Barnes Akathisia Rating Scale.

During the study, four patients discontinued treatment, one due to dystonia, one due to a protocol violation, and two due to parental withdrawal of consent. The most common adverse events were blurred vision, excessive sleepiness or its opposite, insomnia, and headache. Adverse events were typically transient and occurred at equivalent rates across the three different target doses.

The investigators concluded that aripiprazole was well tolerated in female and male children and adolescents, regardless of their psychiatric diagnoses, Dr. Findling said.

The study was funded by Otsuka Pharmaceuticals, which manufactures Abilify.

AACAP and CACAP Joint Annual Meeting: Abstract C-5. Presented Oct. 20, 2005.

Reviewed by Gary D. Vogin, MD

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