Author(s): DelBello MP, Versavel M, Ice K, Keller D, Miceli J
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Abstract OBJECTIVE: This study characterizes the tolerability of ziprasidone in children and adolescents with bipolar mania, schizophrenia, or schizoaffective disorder. METHOD: Sixty-three subjects (aged 10-17 years) entered an open-label study consisting of a 3-week fixed-dose period (Period 1) and a subsequent 24-week flexible-dose period (Period 2). In Period 1, subjects received ziprasidone 80 or 160 mg/d in two divided doses, titrated over 10 days. In Period 2, subjects received flexible doses (20-160 mg/d). Tolerability was evaluated using movement rating scales, laboratory tests, and electrocardiograms. Clinical response was assessed using the Young Mania Rating Scale, the Brief Psychiatric Rating Scale-Anchored Version, and the Clinical Global Impressions-Severity scale. RESULTS: Adverse events (AEs) occurred mostly during dose titration and in the high-dose (160 mg/d) group. The most common AEs during Period 1 were sedation (32\%), somnolence (30\%), and nausea (25\%) and during Period 2 were sedation (30\%), somnolence (30\%), and headache (25\%). The incidence of movement disorder AEs was 22\% and 16\% during Periods 1 and 2, respectively. Six percent of study participants discontinued study participation due to AEs during Period 1 and 20\% discontinued in Period 2. Thirty-three percent of subjects gained >or=7\% of their baseline weight. No Fridericia-corrected QT (QTcF) intervals of >450 ms were observed during Period 1 and only one occurred during Period 2. No QTcF increase >or=60 ms from baseline was observed. Symptom reductions were observed in all patient groups. CONCLUSIONS: No unexpected tolerability findings were observed in this prospective trial of ziprasidone in children and adolescents with bipolar mania, schizophrenia, or schizoaffective disorder. On the basis of the results, a starting dose of 20 mg/d titrated to between 80 and 160 mg/d over 1-2 weeks appears optimal for most patients.
This article was published in J Child Adolesc Psychopharmacol
and referenced in Journal of Depression and Anxiety