Tolerability of oral ziprasidone in children and adolescents with bipolar mania, schizophrenia, or schizoaffective disorder

J Child Adolesc Psychopharmacol. 2008 Oct;18(5):491-9. doi: 10.1089/cap.2008.008.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Antipsychotic Agents / administration & dosage
  • Antipsychotic Agents / adverse effects*
  • Antipsychotic Agents / therapeutic use
  • Bipolar Disorder / drug therapy*
  • Child
  • Dose-Response Relationship, Drug
  • Electrocardiography
  • Female
  • Humans
  • Male
  • Piperazines / administration & dosage
  • Piperazines / adverse effects*
  • Piperazines / therapeutic use
  • Prospective Studies
  • Psychiatric Status Rating Scales
  • Psychotic Disorders / drug therapy
  • Schizophrenia / drug therapy*
  • Severity of Illness Index
  • Thiazoles / administration & dosage
  • Thiazoles / adverse effects*
  • Thiazoles / therapeutic use

Substances

  • Antipsychotic Agents
  • Piperazines
  • Thiazoles
  • ziprasidone