PMID- 18626272
OWN - NLM
STAT- MEDLINE
DCOM- 20081024
LR  - 20151119
IS  - 1533-712X (Electronic)
IS  - 0271-0749 (Linking)
VI  - 28
IP  - 4
DP  - 2008 Aug
TI  - Tolerability and pharmacokinetics of aripiprazole in children and adolescents 
      with psychiatric disorders: an open-label, dose-escalation study.
PG  - 441-6
LID - 10.1097/JCP.0b013e31817dd520 [doi]
AB  - This multicenter, open-label, sequential-cohort, dose-escalation study explored 
      the tolerability and pharmacokinetics (PK) of aripiprazole up to the maximum 
      approved adult dose (30 mg/d) in children and adolescents (aged 10-17 years) 
      preferentially with primary psychiatric diagnoses of a bipolar or schizophrenia 
      spectrum disorder. During a dose-escalation phase, patients received aripiprazole 
      for up to 12 days using forced titration to achieve doses of 20, 25, or 30 mg/d. 
      In the subsequent fixed-dose phase, patients received the maximum dose for that 
      cohort for an additional 14 days. Tolerability in each fixed-dose cohort was 
      assessed by measures including evaluation of spontaneously reported adverse 
      events (AEs) and vital signs. If 4 of 6 patients tolerated the maximum dose for 
      the cohort, the dose was considered tolerated, and enrollment in the next dose 
      level began. Of 21 enrolled patients, 17 completed the fixed-dose phase. 
      Aripiprazole treatment was generally well tolerated, with criteria for 
      tolerability met for all doses tested. All patients experienced at least 1 AE, 
      none of which met the regulatory criteria for a serious AE. There were no deaths 
      or clinically relevant changes in vital signs or weight. Aripiprazole PK seemed 
      to be linear across the tested dose range and was comparable with previous PK 
      observations in adults. This study provides information regarding the 
      tolerability and PK of aripiprazole up to the maximum adult dose in children and 
      adolescents. These data provided support for exploration of a 30-mg/d dose in 
      child/adolescent schizophrenia and bipolar disorder.
FAU - Findling, Robert L
AU  - Findling RL
AD  - Child and Adolescent Psychiatry, University Hospitals Case Medical Center, 11100 
      Euclid Ave, Cleveland, OH, USA. robert.findling@uhhospitals.org
FAU - Kauffman, Ralph E
AU  - Kauffman RE
FAU - Sallee, Floyd R
AU  - Sallee FR
FAU - Carson, William H
AU  - Carson WH
FAU - Nyilas, Margaretta
AU  - Nyilas M
FAU - Mallikaarjun, Suresh
AU  - Mallikaarjun S
FAU - Shoaf, Susan E
AU  - Shoaf SE
FAU - Forbes, Robert A
AU  - Forbes RA
FAU - Boulton, David W
AU  - Boulton DW
FAU - Pikalov, Andrei
AU  - Pikalov A
LA  - eng
SI  - ClinicalTrials.gov/NCT00102479
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Psychopharmacol
JT  - Journal of clinical psychopharmacology
JID - 8109496
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Piperazines)
RN  - 0 (Quinolones)
RN  - 82VFR53I78 (Aripiprazole)
SB  - IM
MH  - Adolescent
MH  - Antipsychotic Agents/administration & dosage/*adverse 
      effects/*pharmacokinetics/therapeutic use
MH  - Aripiprazole
MH  - Bipolar Disorder/drug therapy
MH  - Child
MH  - Cohort Studies
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Piperazines/administration & dosage/*adverse 
      effects/*pharmacokinetics/therapeutic use
MH  - Quinolones/administration & dosage/*adverse effects/*pharmacokinetics/therapeutic 
      use
MH  - Schizophrenia/drug therapy
EDAT- 2008/07/16 09:00
MHDA- 2008/10/25 09:00
CRDT- 2008/07/16 09:00
PHST- 2008/07/16 09:00 [pubmed]
PHST- 2008/10/25 09:00 [medline]
PHST- 2008/07/16 09:00 [entrez]
AID - 00004714-200808000-00012 [pii]
AID - 10.1097/JCP.0b013e31817dd520 [doi]
PST - ppublish
SO  - J Clin Psychopharmacol. 2008 Aug;28(4):441-6. doi: 10.1097/JCP.0b013e31817dd520.