title: An open-label study of aripiprazole: pharmacokinetics, tolerability, and effectiveness in children and adolescents with conduct disorder.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University Hospitals Case Medical Center, Cleveland, OH 44106, USA. robert.findling@UHhospitals.org
authors.forename: Robert L
authors.initials: RL
authors.lastname: Findling
authors.forename: Ralph
authors.initials: R
authors.lastname: Kauffman
authors.forename: Floyd R
authors.initials: FR
authors.lastname: Sallee
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Salazar
authors.forename: Vaishali
authors.initials: V
authors.lastname: Sahasrabudhe
authors.forename: Georgia
authors.initials: G
authors.lastname: Kollia
authors.forename: David M
authors.initials: DM
authors.lastname: Kornhauser
authors.forename: Nimish N
authors.initials: NN
authors.lastname: Vachharajani
authors.forename: Sheila
authors.initials: S
authors.lastname: Assuncao-Talbott
authors.forename: Suresh
authors.initials: S
authors.lastname: Mallikaarjun
authors.forename: Taro
authors.initials: T
authors.lastname: Iwamoto
authors.forename: Robert D
authors.initials: RD
authors.lastname: McQuade
authors.forename: David W
authors.initials: DW
authors.lastname: Boulton
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Blumer
mesh_terms: D000293:Adolescent; D000367:Age Factors; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D000068180:Aripiprazole; D002648:Child; D019955:Conduct Disorder / Q000097:blood* / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010879:Piperazines / Q000009:adverse effects* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D011446:Prospective Studies; D015363:Quinolones / Q000009:adverse effects* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D014202:Tremor / Q000139:chemically induced / Q000175:diagnosis; D014839:Vomiting / Q000139:chemically induced / Q000175:diagnosis
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole