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• W2071440082 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 ≥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 ≥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." @default.
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• W2071440082 date "2008-10-01" @default.
• W2071440082 modified "2023-09-28" @default.
• W2071440082 title "Tolerability of Oral Ziprasidone in Children and Adolescents with Bipolar Mania, Schizophrenia, or Schizoaffective Disorder" @default.
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• W2071440082 doi "https://doi.org/10.1089/cap.2008.008" @default.
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