An open-label study of aripiprazole: pharmacokinetics, tolerability, and effectiveness in children and adolescents with conduct disorder.
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.
Findling
Robert L
RL
University Hospitals Case Medical Center, Cleveland, OH 44106, USA. robert.findling@UHhospitals.org
Kauffman
Ralph
R
Sallee
Floyd R
FR
Salazar
Daniel E
DE
Sahasrabudhe
Vaishali
V
Kollia
Georgia
G
Kornhauser
David M
DM
Vachharajani
Nimish N
NN
Assuncao-Talbott
Sheila
S
Mallikaarjun
Suresh
S
Iwamoto
Taro
T
McQuade
Robert D
RD
Boulton
David W
DW
Blumer
Jeffrey
J
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
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole