Efficacy, long-term safety, and tolerability of ziprasidone in children and adolescents with bipolar disorder.

ABSTRACT:

Objective

The purpose of this study was to evaluate the short- and long-term efficacy and safety of ziprasidone in children and adolescents with bipolar I disorder.

Methods

Subjects 10-17 years of age with a manic or mixed episode associated with bipolar I disorder participated in a 4 week, randomized, double-blind, placebo-controlled multicenter trial (RCT) followed by a 26 week open-label extension study (OLE). Subjects were randomized 2:1 to initially receive flexible-dose ziprasidone (40-160 mg/day, based on weight) or placebo. Primary outcome was the change in Young Mania Rating Scale (YMRS) scores from baseline. Safety assessments included weight and body mass index (BMI), adverse events (AEs), vital signs, laboratory measures, electrocardiograms, and movement disorder

SUBMITTER: Findling RL 

PROVIDER: S-EPMC3804078 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature