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

Study Overview
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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.

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.

Official Title
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Post-Marketing Surveillance (PMS) Study to Evaluate Safety and Efficacy of Zeldox Capsule

Conditions
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Bipolar Disorder, Schizophrenia

Intervention / Treatment
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* Drug: ziprasidone


Participation Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observational cohort<br> | Drug: ziprasidone<br>* This is a non-interventional, pharmacovigilance study, therefore patients are on ziprasidone as prescribed by their doctor.<br>* Other names: Geodon, Zeldox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population | CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected. | Baseline up to Week 8 | 
| Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population | CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected. | Baseline up to Week 8 | 
| Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT | CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected. | Baseline up to Week 8 | 
| Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP | CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected. | Baseline up to Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regulatory Post-Marketing Surveillance, Regulatory Pharmacovigilance, ziprasidone