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A prospective open-label treatment trial of ziprasidone monotherapy in children and adolescents with bipolar disorder

Authors

  • Joseph Biederman,

    1. Pediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston
    2. Department of Psychiatry, Harvard Medical School, Cambridge, MA, USA
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  • Eric Mick,

    1. Pediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston
    2. Department of Psychiatry, Harvard Medical School, Cambridge, MA, USA
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  • Thomas Spencer,

    1. Pediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston
    2. Department of Psychiatry, Harvard Medical School, Cambridge, MA, USA
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  • Meghan Dougherty,

    1. Pediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston
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  • Megan Aleardi,

    1. Pediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston
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  • Janet Wozniak

    1. Pediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston
    2. Department of Psychiatry, Harvard Medical School, Cambridge, MA, USA
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  • JB receives/d research support from, is/has been a speaker for, or is/ has been on the advisory board for Shire Laboratories, Eli Lilly & Co., Pfizer, McNeil, Abbott, Bristol-Myers-Squibb, New River Pharmaceuticals, Cephalon, Janssen, Novartis, UCB Pharma, AstraZeneca, Forest Laboratories, GlaxoSmithKline, Neurosearch, Stanley Medical Institute, Inc., Lilly Foundation, Prechter Foundation, NIMH, NICHD and NIDA. EM receives/d grant support from McNeil Pediatrics and Janssen Pharmaceuticals. TS receives research support from Shire Laboratories, Inc., Eli Lilly & Co., GlaxoSmithKline, Pfizer, McNeil, Novartis, and NIMH; serves on the speakers bureaus for GlaxoSmithKline, Eli Lilly & Co., Novartis, Wyeth Ayerst, Shire Laboratories, Inc., McNeil; and is on the advisory boards for Shire Laboratories, Inc., Eli Lilly & Co., GlaxoSmithKline, Pfizer, McNeil, and Novartis. MD, MA, and JW have no conflicts to disclose.

Joseph Biederman, Massachusetts General Hospital, Pediatric Psychopharmacology Research, 32 Fruit Street, Yawkey Center for Outpatient Care-Yaw-6A, Boston, MA 02114, USA. Fax: 617 724 1540; e-mail: jbiederman@partners.org

Abstract

Objective:  To assess the effectiveness and tolerability of ziprasidone for treating pediatric mania.

Methods:  This was an eight-week, open-label, prospective study of ziprasidone monotherapy (57.3 ± 33.9 mg/day) in 21 bipolar youth [manic, mixed, or bipolar not otherwise specified (NOS); 6–17 years old]. Assessments included the Young Mania Rating Scale (YMRS), Clinical Global Impressions-Improvement scale (CGI-I), and Brief Psychiatric Rating Scale (BPRS). Adverse events were assessed through spontaneous self-reports, vital signs, weight monitoring, and laboratory analysis.

Results:  Fourteen of the 21 youth (67%) completed the study. Ziprasidone treatment was associated with clinically and statistically significant improvement in mean YMRS scores (−10.8 ± 8.4, p < 0.0001) and 57% had a CGI-I ≤2 at endpoint. Ziprasidone was well tolerated with no statistically significant increase in body weight (0.6 ± 0.4 kg, p = 0.2) or QTc interval (−3.7 ± 4.7, p = 0.5).

Conclusions:  Open-label ziprasidone treatment was associated with a significant short-term improvement of symptoms of pediatric bipolar disorder. Future placebo-controlled, double-blind studies are warranted.

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