Status:

COMPLETED

Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.

Lead Sponsor:

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Conditions:

Affective Psychosis, Bipolar

Mania

Eligibility:

All Genders

18+ years

Brief Summary

Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.

Detailed Description

Method: Consecutive patient sampling. Patients were included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.

Eligibility Criteria

Inclusion

  • Manic and mixed episodes of up to moderate severity in patients with Type I and II bipolar disorder and schizoaffective disorder; either first diagnosed or repeated episodes

Exclusion

  • Hypersensitivity to ziprasidone
  • prolonged QTc interval
  • coadministration with substances that are prolonging the QTc interval
  • recent acute MI, cardiac failure, patients with arrhythmias treated with class IA or III medicaments

Key Trial Info

Start Date :

April 1 2007

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

379 Patients enrolled

Trial Details

Trial ID

NCT00454883

Start Date

April 1 2007

End Date

December 1 2007

Last Update

February 21 2021

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