An open-label trial of aripiprazole monotherapy in children and adolescents with bipolar disorder.
BACKGROUND
Aripiprazole is a novel second-generation antipsychotic approved for the treatment of bipolar disorder in adults but there is no systematic data available in pediatric bipolar disorder.


METHODS
This was an 8-week, open-label, prospective study of aripiprazole 9.4+/-4.2 mg/day monotherapy to assess the efficacy and tolerability of this compound in treating pediatric bipolar disorder. Assessments included the Young Mania Rating Scale, Clinical Global Impressions-Improvement scale, and Brief Psychiatric Rating Scale. Adverse events were assessed through spontaneous self-reports, vital signs weight monitoring, and laboratory analysis.


RESULTS
Fifteen of the 19 bipolar youth (79%) completed the study. Aripiprazole treatment was associated with clinically and statistically significant improvement in mean Young Mania Rating Scale scores (-18.0+/-6.9, P<.0001). With the important exception of two cases of extrapyramidal symptoms that precipitated dropout, aripiprazole was well tolerated with no statistically significant increase in body weight (1.8+/-1.7 kg, P=.2).


CONCLUSIONS
Open-label aripiprazole treatment was beneficial in the treatment of mania in youth with bipolar disorder. Future placebo-controlled, double-blind studies are warranted.
Biederman
Joseph
J
Joint Program in Pediatric Psychopharmacology Research Office, Massachusetts General Hospital, Boston, MA 02114, USA. jbiederman@partners.org
Mick
Eric
E
Spencer
Thomas
T
Doyle
Robert
R
Joshi
Gagan
G
Hammerness
Paul
P
Kotarski
Megan
M
Aleardi
Megan
M
Wozniak
Janet
J
D000293:Adolescent; D000068180:Aripiprazole; D001289:Attention Deficit Disorder with Hyperactivity / Q000453:epidemiology; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D010054:Brief Psychiatric Rating Scale; D002648:Child; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008297:Male; D010879:Piperazines / Q000627:therapeutic use*; D015363:Quinolones / Q000627:therapeutic use*; D011795:Surveys and Questionnaires