Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)
Recruiting in Palo Alto (17 mi)
+91 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the regimen.
Eligibility Criteria
Inclusion Criteria
Adults meeting DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for Bipolar I Disorder (currently with manic or mixed symptoms)
Treatment Details
Interventions
- Placebo (Drug)
- Ziprasidone Oral Capsule (Atypical Antipsychotic)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ZiprasidoneExperimental Treatment1 Intervention
Active treatment, double-blind, randomized arm
Group II: PlaceboPlacebo Group1 Intervention
Placebo treatment, double-blind, randomized arm
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Pfizer Investigational SiteLexington, KY
Pfizer Investigational SiteOmaha, NE
Pfizer Investigational SiteRochester, NY
Pfizer Investigational SiteColumbus, OH
More Trial Locations
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Who Is Running the Clinical Trial?
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Lead Sponsor