NCT01124877

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

26 Week Open Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	ziprasidone oral capsules	Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength will be provided. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing \<45 kg, the doses will range from 20 mg BID to 40 mg BID.

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-05-17
• Last updated: 2021-02-21