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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.3,391 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

3,391

Conditions

Bipolar Disorder Schizophrenia

Interventions

ziprasidoneDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: Baseline up to Week 8

Data from ClinicalTrials.gov

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