drugset / Trial / NCT01124877

Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

NCT01124877

Phase 3 Withdrawn Viatris Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and tolerability of ziprasidone during a long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder (Manic or Mixed).

Timeline

Start
2010-07
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Ziprasidone Small molecule 20 mg Oral
Subject Ziprasidone Small molecule 40 mg Oral
Subject Ziprasidone Small molecule 60 mg Oral
Subject Ziprasidone Small molecule 80 mg Oral

Indications