At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 680 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Ziprasidone 40mgfrom 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.
A Three-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Add-On Oral Ziprasidone in Subjects With Acute Mania Treated With Lithium or Divalproex
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Apr 10, 2006·Updated Mar 29, 2021
In Brief
A Phase 3 clinical trial evaluating Placebo and Ziprasidone for Bipolar Disorder. Completed, enrolled 680 participants across 66 sites.
Detailed Summary
3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedApr 2006
Primary CompletionDec 2008
TodayJul 2026
First PostedApr 10, 2006
Enrollment StartApr 1, 2006
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 20.2 years ago
Interventions
Placebodrug
Placebo with mood stabilizer (either lithium or divalproex)
Ziprasidonedrug
Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)
Ziprasidonedrug
Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)