NCT01113541

One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome

A One-year, Phase III, Open-label, Non-comparative Trial of the Effect of Ziprasidone HCl on Metabolic Syndrome Risk Factors in Patients With Bipolar Disorder

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (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

The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.

Detailed description

The trial was terminated prematurely on December 14, 2010, due to inability to recruit the planned number of subjects and shifting organizational priorities. The decision to terminate the trial was not based on any safety or efficacy concerns.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Ziprasidone HCL (oral)	Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40-160 mg total daily dose) for up to 1 year.

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-04-30
• Last updated: 2021-03-03
• Results posted: 2012-07-09

Locations

10 sites across 1 country: Canada