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An Open-Label Trial of Aripiprazole Monotherapy in Children and Adolescents with Bipolar Disorder

Published online by Cambridge University Press:  07 November 2014

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

Type
Original Research
Information
CNS Spectrums , Volume 12 , Issue 9 , September 2007 , pp. 683 - 689
Copyright
Copyright © Cambridge University Press 2007

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References

REFERENCES

1.Tohen, M, Ketter, TA, Zarate, CA, et al.Olanzapine versus divalproex sodium for the treatment of acute mania and maintenance of remission: a 47-week study. Am J Psychiatry. 2003;160:1263–1271.CrossRefGoogle ScholarPubMed
2.Keck, PE Jr, Versiani, M, Potkin, S, et al.Ziprasidone in the treatment of acute bipolar mania: a three-week, placebo-controlled, double-blind, randomized trial. Am J Psychiatry. 2003;160:741–748.CrossRefGoogle Scholar
3.Perlis, RH, Welge, JA, Vornik, LA, Hirschfeld, RM, Keck, PE Jr.Atypical antipsychotics in the treatment of mania: a meta-analysis of randomized, placebo-controlled trials. J Clin Psychiatry. 2006;67:509–516.CrossRefGoogle Scholar
4.Frazier, JA, Biederman, J, Tohen, M, et al.A prospective open-label treatment trial of olanzapine monotherapy in children and adolescents with bipolar disorder. J Child Adolesc Psychopharmacol. 2001;11:239–250.CrossRefGoogle ScholarPubMed
5.Biederman, J, Mick, E, Wozniak, J, Aleardi, M, Spencer, T, Faraone, SV. An open-label trial of risperidone in children and adolescents with bipolar disorder. J Child Adolesc Psychopharmacol. 2005;15:311–317.CrossRefGoogle ScholarPubMed
6.Biederman, J, Mick, E, Hammerness, P, et al.Open-label, 8-week trial of olanzapine and risperidone for the treatment of bipolar disorder in preschool-age children. Biol Psychiatry. 2005;58:589–594.CrossRefGoogle ScholarPubMed
7.DelBello, MP, Kowatch, RA, Adler, CM, et al.A double-blind randomized pilot study comparing quetiapine and divalproex for adolescent mania. J Am Acad Child Adolesc Psychiatry. 2006;45:305–313.CrossRefGoogle ScholarPubMed
8.Biederman, J, McDonnell, MA, Wozniak, J, et al.Aripiprazole in the treatment of pediatric bipolar disorder: a systematic chart review. CNS Spectr. 2005;10:141–148.CrossRefGoogle ScholarPubMed
9.Barzman, DH, Delbello, MP, Kowatch, RA, et al.The effectiveness and tolerability of aripiprazole for pediatric bipolar disorders: a retrospective chart review. J Child Adolesc Psychopharmacol. 2004;14:593–600.CrossRefGoogle ScholarPubMed
10.Gibson, AP, Crismon, ML, Mican, LM, Fischer, C. Effectiveness and tolerability of aripiprazole in child and adolescent inpatients: a retrospective evaluation. Int Clin Psychopharmacol. 2007;22:101–105.CrossRefGoogle ScholarPubMed
11.Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Association; 1994.Google Scholar
12.Fristad, MA, Weller, RA, Weller, EB. The Mania Rating Scale (MRS): further reliability and validity studies with children. Ann Clin Psychiatry. 1995;7:127–132.CrossRefGoogle ScholarPubMed
13.Fristad, MA, Weller, EB, Weller, RA. The Mania Rating Scale: can it be used in children? A preliminary report. J Am Acad Child Adolesc Psychiatry. 1992;31:252–257.CrossRefGoogle ScholarPubMed
14.Young, R, Biggs, J, Ziegler, V, Meyer, D. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978;133:429–435.CrossRefGoogle ScholarPubMed
15.Youngstrom, EA, Danielson, CK, Findling, RL, Gracious, BL, Calabrese, JR. Factor structure of the Young Mania Rating Scale for use with youths ages 5 to 17 years. J Clin Child Adolesc Psychol. 2002;31:567–572.CrossRefGoogle Scholar
16.Lachar, D, Bailley, SE, Rhoades, HM, et al.New subscales for an anchored version of the Brief Psychiatric Rating Scale: construction, reliability, and validity in acute psychiatric admissions. Psychol Assess. 2001;13:384–395.CrossRefGoogle ScholarPubMed
17.National Institute of Mental Health. CGI (Clinical Global Impression) Scale. Psychopharmacol Bull. 1985;21:839–844.Google Scholar
18.Keck, PJ, Marcus, R, Tourkodimitris, S, et al.A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania. Am J Psychiatry. 2003;160:1651–1658.CrossRefGoogle ScholarPubMed
19.Tohen, M, Zarate, CA Jr, Centorrino, F, Hegarty, JI, Froeschl, M, Zarate, SB. Risperidone in the treatment of mania. J Clin Psychiatry. 1996;57:249–253.Google ScholarPubMed
20.Wozniak, J, Biederman, J, Kiely, K, et al.Mania-like symptoms suggestive of childhood-onset bipolar disorder in clinically referred children. J Am Acad Child Adolesc Psychiatry. 1995;34:867–876.CrossRefGoogle ScholarPubMed
21.Armenteros, J, Whitaker, A, Welikson, M, Stedge, D, Gorman, J. Risperidone in adolescents with schizophrenia: an open pilot study. J Am Acad Child Adolesc Psychiatry. 1997;36:694–700.CrossRefGoogle ScholarPubMed
22.McDougle, CJ, Holmes, JP, Bronson, MR, et al.Risperidone treatment of children and adolescents with pervasive developmental disorders: a prospective open-label study. J Am Acad Child Adolesc Psychiatry. 1997;36:685–693.CrossRefGoogle ScholarPubMed
23.Quintana, U, Keshavan, M. Case study: risperidone in children and adolescents with schizophrenia. J Am Acad Child Adolesc Psychiatry. 1995;34:1292–1296.CrossRefGoogle ScholarPubMed