At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 238 enrolled
Drug / intervention
Ziprasidone oral capsules +1 moredrug
Likely dose
Ziprasidone oral capsules 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Four Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Nov 22, 2005·Updated Mar 3, 2021
In Brief
A Phase 3 clinical trial evaluating Ziprasidone oral capsules and placebo oral capsules for Bipolar Disorder. Completed, enrolled 238 participants across 50 sites.
Detailed 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 I disorder (manic or mixed).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2005
Enrollment StartJan 2006
Primary CompletionJul 2007
TodayJul 2026
First PostedNov 22, 2005
Enrollment StartJan 1, 2006
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 20.6 years ago
Interventions
Ziprasidone oral capsulesdrug
Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.
placebo oral capsulesdrug
Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.