An open-label study of aripiprazole: Pharmacokinetics, tolerability, and effectiveness in children and adolescents with conduct disorder

Robert L. Findling, Ralph Kauffman, Floyd R. Sallee, Daniel E. Salazar, Vaishali Sahasrabudhe, Georgia Kollia, David M. Kornhauser, Nimish N. Vachharajani, Sheila Assuncao-Talbott, Suresh Mallikaarjun, Taro Iwamoto, Robert D. McQuade, David W. Boulton, Jeffrey Blumer

Research output: Contribution to journalArticle

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 <25 kg, 2 mg/day; subjects 25-50 kg, 5 mg/day; subjects >50-70 kg, 10 mg/day; and subjects >70 kg, 15 mg/day. Due to vomiting and sedation, this schedule was revised to: <25 kg, 1 mg/day; 25-50 kg, 2 mg/day; >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.

Original languageEnglish (US)
Pages (from-to)431-439
Number of pages9
JournalJournal of child and adolescent psychopharmacology
Volume19
Issue number4
DOIs
StatePublished - Aug 1 2009
Externally publishedYes

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Psychiatry and Mental health
  • Pharmacology (medical)

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    Findling, R. L., Kauffman, R., Sallee, F. R., Salazar, D. E., Sahasrabudhe, V., Kollia, G., Kornhauser, D. M., Vachharajani, N. N., Assuncao-Talbott, S., Mallikaarjun, S., Iwamoto, T., McQuade, R. D., Boulton, D. W., & Blumer, J. (2009). An open-label study of aripiprazole: Pharmacokinetics, tolerability, and effectiveness in children and adolescents with conduct disorder. Journal of child and adolescent psychopharmacology, 19(4), 431-439. https://doi.org/10.1089/cap.2008.0111