NCT00312494

3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 680 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Placebo with mood stabilizer (either lithium or divalproex)
DRUG	Ziprasidone	Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)
DRUG	Ziprasidone	Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-04-10
• Last updated: 2021-03-29
• Results posted: 2010-01-22

Locations

66 sites across 1 country: United States