A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3391 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2010-02-28

Brief Summary

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This is a regulatory-required non-interventional pharmacovigilance study exploring the safety profile of ziprasidone HCL monohydrate 20mg, 40mg, 60mg, 80mg in the real world patient population, thus, safety (and/or efficacy) signals will be checked at every visit during the contracted study period until the maximum study end date, per the protocol, of April 2010.

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UNKNOWN

Detailed Description

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All patients diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features will be included in the study.

Conditions

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Bipolar Disorder Schizophrenia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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observational cohort

ziprasidone

Intervention Type DRUG

This is a non-interventional, pharmacovigilance study, therefore patients are on ziprasidone as prescribed by their doctor.

Interventions

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ziprasidone

This is a non-interventional, pharmacovigilance study, therefore patients are on ziprasidone as prescribed by their doctor.

Intervention Type DRUG

Other Intervention Names

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Geodon, Zeldox

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with schizophrenia

Exclusion Criteria

* Patients who have known hypersensitivity to any ingredient of the product
* Patients who have had a recent acute myocardial infarction
* Patients who have uncompensated heart failure
* Patients who have conditions with a potential to increase QT interval (QT-interval prolongation or history of QT prolongation; congenital long QT syndrome; use with other drugs known to increase the QT interval; arrhythmias treated with class I and III antiarrhythmic drugs)

Eligible Sex

ALL

Accepts Healthy Volunteers

No