Acute treatment of pediatric bipolar I disorder, manic or mixed episode, with aripiprazole: a randomized, double-blind, placebo-controlled study.
OBJECTIVE
To determine the efficacy and safety of aripiprazole for the treatment of pediatric bipolar I disorder, manic or mixed episode, with or without psychotic features.


METHODS
Subjects were enrolled between March 2005 and February 2007 in a randomized, multicenter, double-blind 4-week study of aripiprazole 10 mg/d, aripiprazole 30 mg/d, and placebo. Subjects (n = 296) were 10 to 17 years old with a DSM-IV diagnosis of bipolar I disorder with current manic or mixed episodes, with or without psychotic features, and a Young Mania Rating Scale (YMRS) score > or = 20. The primary efficacy variable was change from baseline in the YMRS total score.


RESULTS
Both doses of aripiprazole were superior to placebo on the YMRS total score beginning at week 1 and continuing through week 4. Aripiprazole 10 mg and 30 mg were more effective than placebo on global improvement, mania, and overall bipolar illness outcome measures. Response ( > or = 50% reduction in YMRS total score) at week 4 was achieved by 44.8%, 63.6%, and 26.1% of subjects in the aripiprazole 10 mg, aripiprazole 30 mg, and placebo groups, respectively (P < .01 both doses vs placebo). Both doses were generally well tolerated. The most common adverse events were extrapyramidal disorder and somnolence; rates were higher for aripiprazole 30 mg compared with aripiprazole 10 mg. Average weight gain was not significantly different between the aripiprazole 10 mg (+0.82 kg) or 30 mg (+1.08 kg) groups compared with the placebo group (+0.56 kg) (P = .35 and P = .13, respectively).


CONCLUSIONS
Aripiprazole in daily doses of 10 mg or 30 mg is an effective and generally well-tolerated acute treatment for pediatric subjects with bipolar I mania or mixed episodes.


BACKGROUND
clinicaltrials.gov Identifier: NCT00110461.
Findling
Robert L
RL
Department of Psychiatry, Division of Child and Adolescent Psychiatry, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH 44106, USA. robert.findling@uhhospitals.org
Nyilas
Margaretta
M
Forbes
Robert A
RA
McQuade
Robert D
RD
Jin
Na
N
Iwamoto
Taro
T
Ivanova
Svetlana
S
Carson
William H
WH
Chang
Kiki
K
D000293:Adolescent; D000367:Age Factors; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000068180:Aripiprazole; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D002648:Child; D002675:Child, Preschool; D015897:Comorbidity; D003866:Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010879:Piperazines / Q000008:administration & dosage / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D015363:Quinolones / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole