NCT00265330

Safety and Tolerability of 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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 169 (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 long-term open-label administration 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	Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-12-14
• Last updated: 2021-03-25
• Results posted: 2009-04-03

Locations

41 sites across 1 country: United States