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CNS Spectr. 2007 Sep;12(9):683-9.

An open-label trial of aripiprazole monotherapy in children and adolescents with bipolar disorder.

Author information

  • 1Joint Program in Pediatric Psychopharmacology Research Office, Massachusetts General Hospital, Boston, MA 02114, USA. jbiederman@partners.org

Abstract

INTRODUCTION:

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).

CONCLUSION:

Open-label aripiprazole treatment was beneficial in the treatment of mania in youth with bipolar disorder. Future placebo-controlled, double-blind studies are warranted.

PMID:
17805214
[PubMed - indexed for MEDLINE]
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