Ziprasidone in adolescents with schizophrenia: results from a placebo-controlled efficacy and long-term open-extension study.

ABSTRACT:

Objective

The purpose of this study was to evaluate the short- and long-term efficacy, safety, and tolerability of ziprasidone in adolescents with schizophrenia.

Methods

Subjects ages 13-17 years with schizophrenia (American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed. [DSM-IV]) were enrolled in a 6 week, randomized, double-blind, placebo-controlled multicenter trial (RCT) followed by a 26 week open-label extension study (OLE). Subjects were randomized in a 2:1 ratio to flexible-dose oral ziprasidone (40-160 mg/day, based on weight) or placebo. Primary end-point was change from baseline in Brief Psychiatric Rating Scale-Anchored (BPRS-A) total score. Safety assessments included adverse events, vital signs, laboratory measures, elect

SUBMITTER: Findling RL 

PROVIDER: S-EPMC3804318 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature