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

Joseph Biederman, Eric Mick, Thomas Spencer, Robert Doyle, Gagan Joshi, Paul Hammerness, Megan Kotarski, Megan Aleardi, Janet Wozniak

Research output: Contribution to journalArticlepeer-review

72 Scopus citations

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: Th is was an 8-week, open-label, proxspective 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.

Original languageEnglish
Pages (from-to)683-689
Number of pages7
JournalCNS Spectrums
Volume12
Issue number9
DOIs
StatePublished - Sep 2007
Externally publishedYes

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