Aripiprazole Reduces Aggressive Behavior in Children

November 11, 2003

Nov. 11, 2003 (Orlando) — The use of aripiprazole to reduce aggressive behavior in children has been found to be effective, safe, and well tolerated, according to a study presented here at the 16th U.S. Psychiatric & Mental Health Congress.

"This is the first prospective study that provides [an] important dosing strategy for aripiprazole in children and adolescents," Robert Findling, MD, from Case Western University in Cleveland, Ohio, told Medscape in an interview.

In previous clinical studies, aripiprazole has been shown to have good tolerability, efficacy, and safety in adults (>18 years). The researchers attempted to establishing the pharmacokinetics, safety, and dosing regimen for children and adolescents with conduct disorder.

An open-label, 15-day study was conducted in 12 children (aged 6-12 years) and 11 adolescents (aged 13-17 years) diagnosed with either a DSM-IV conduct disorder or oppositional defiant disorder and a score of 2 or 3 (mild or moderately severe) on the Rating of Aggression Against People and/or Property (RAAPP) scale.

The first five patients were given doses of aripiprazole of 2 to15 mg/day based on body weight. After observing less-than-optimal tolerability, dosing was adjusted accordingly (weight <25 kg = 1 mg, 25-50 kg = 2 mg, 50-70 kg = 5 mg, and >70 kg = 10 mg). Patients were treated for 14 days, after which those who completed the study were given the opportunity to enter a 36-month extension phase.

"The 36-month extension phase will provide very important additional safety data in the treatment of adolescents with aripiprazole," Dr. Findling said.

The C max and area under the curve values of aripiprazole were generally higher (two- to sevenfold) for the patients who received constant daily doses. Results were similar to those seen in adults. Aripiprazole was fairly well tolerated, with some adverse events such as vomiting and somnolence, but these generally occurred before dosing regimens were optimized.

The investigators write in their abstract, "Preliminary data suggest that aripiprazole improves symptoms of conduct disorder in both children and adolescents."

The study was funded by Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co., Ltd.

16th U.S. Psychiatric & Mental Health Congress: Abstract 33. Presented Nov. 6, 2003.

Reviewed by Gary D. Vogin, MD

Robert Glassman is a freelance writer for Medscape.

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