NCT02075047

Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder

A PHASE 3, MULTICENTER, FOUR-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EFFICACY AND SAFETY TRIAL OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (CURRENT OR MOST RECENT EPISODE MANIC)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (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 determine if ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	placebo oral capsules	Placebo matching the oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects \<45 kg having a target dose range of 60-80 mg/day and subjects \>/= 45 kg having a target dose range of 120-180 mg/day.
DRUG	ziprasidone oral capsules	Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects \<45 kg having a target dose range of 60-80 mg/day and subjects \>/= 45 kg having a target dose range of 120-180 mg/day.

Timeline

• Start date: 2014-05-23
• Primary completion: 2020-04-11
• Completion: 2020-05-18
• First posted: 2014-03-03
• Last updated: 2021-06-16
• Results posted: 2021-04-01

Locations

50 sites across 2 countries: United States, Ukraine

Regulatory

• FDA-regulated drug study