An Open-Label Study of Aripiprazole: Pharmacokinetics, Tolerability, and Effectiveness in Children and Adolescents with Conduct Disorder

Abstract

Objectives: This study evaluated flexible-dose pharmacokinetics, safety, and effectiveness of aripiprazole in children and adolescents with conduct disorder (CD). Methods: This open-label, 15-day, three-center study with an optional 36-month extension enrolled a total of 23 patients: 12 children (6–12 years) and 11 adolescents (13–17 years) with CD and a score of 2–3 on the Rating of Aggression Against People and/or Property (RAAPP). Initially, the protocol used the following dosing: subjects 50–70 kg, 10 mg/day; and subjects >70 kg, 15 mg/day. Due to vomiting and sedation, this schedule was revised to: 50–70 kg, 5 mg/day; and >70 kg, 10 mg/day. Results: Aripiprazole pharmacokinetics were linear, and steady state appeared to be attained within 14 days. Both groups demonstrated improvements in RAAPP scores and Clinical Global Impressions–Severity (CGI-S) scores. Adverse events were similar to the known profile for aripiprazole in adults. Conclusion: The pharmacokinetics of aripiprazole in children and adolescents are linear and comparable with those in adults. Aripiprazole was generally well-tolerated in patients with CD, particularly after protocol adjustments, with improvements in aggressive behavior.