Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)

• Status: Withdrawn
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with Bipolar l Disorder (Manic or Mixed).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Ziprasidone

Criteria

Inclusion Criteria:

• Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for Bipolar I disorder (manic or mixed)

• At the screening and baseline visits, subjects must have a Young Mania Rating Scale (YMRS) score of at least 17.

• The subject must have a Body Mass Index (BMI) z score between -1.65 and +2.00, inclusive

Exclusion Criteria:

• Imminent risk of suicide or homicide, as judged by the site investigator

• Any history of serious or unstable illness

• Risk for prolonged QT