NCT00483548

Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

A Six-Week, Double-Blind, Multicenter, Placebo Controlled Study Evaluating The Efficacy And Safety Of Flexible Doses Of Oral Ziprasidone As Add-On, Adjunctive Therapy With Lithium, Valproate Or Lamotrigine In Bipolar I Depression

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of these mood stabilizers for at least 4 weeks.

Conditions

• Bipolar Disorder
• Depression, Bipolar

Interventions

Type	Name	Description
DRUG	Ziprasidone	Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day.
DRUG	Placebo	Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-06-07
• Last updated: 2021-03-10
• Results posted: 2010-02-23

Locations

70 sites across 3 countries: United States, Australia, India