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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 and Janet Wozniak...

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.

Copyright

Corresponding author

Please direct all correspondence to: Joseph Biederman, MD, YAW 6900, Massachusetts General Hospital, Pediatric Psychopharmacology Research, 55 Fruit Street. Boston, MA 02114; Tel: 617-726-1743, Fax: 617-724-1540; E-mail: jbiederman@partners.org.

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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 and Janet Wozniak...

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