Brief Report A prospective open-label treatment trial of ziprasidone monotherapy in children and adolescents with bipolar disorder In recent years, the atypical neuroleptics have been increasingly used in the treatment of adults and youth with bipolar disorder (1, 2). The unique pharmacological profile of this class of agents with a combined dopaminergic and serotonergic effect appears to confer them mood-stabilizing properties and a lesser risk for tardive dyskinesia (3) than conventional, first-generation neuroleptics. Large- scale, multi-site, placebo-controlled, randomized clinical trials have documented the efficacy and safety of olanzapine (4), risperidone (5), quetiapine (6–9), and aripiprazole (10), in the treatment of adults with bipolar disorder. These studies led to the FDA approval of olanzapine, risperidone, quetiapine, aripiprazole and ziprasidone as mono- therapy for the treatment of adults with bipolar disorder. Consistent with these results, recent Biederman J, Mick E, Spencer T, Dougherty M, Aleardi M, Wozniak J. A prospective open-label treatment trial of ziprasidone monotherapy in children and adolescents with bipolar disorder. Bipolar Disord 2007: 9: 888–894. ª Blackwell Munksgaard, 2007 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 ¼ 0.2) or QTc interval ()3.7 ± 4.7, p ¼ 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. Joseph Biederman a,b , Eric Mick a,b , Thomas Spencer a,b , Meghan Dougherty a , Megan Aleardi a and Janet Wozniak a,b a Pediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston, b Department of Psychiatry, Harvard Medical School, Cambridge, MA, USA Key words: bipolar disorder – children – ziprasidone Received 9 March 2006, revised and accepted for publication 26 October 2006 Corresponding author: 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 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 Founda- tion, 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. Bipolar Disorders 2007: 9: 888–894 Copyright ª Blackwell Munksgaard 2007 BIPOLAR DISORDERS 888