Large Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Olanzapine; Drug: Ziprasidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00418171

A1281062

Details and patient eligibility

About

The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality.

Enrollment: 18,239 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients newly treated for schizophrenia and those receiving continuing treatment will be eligible if the treating psychiatrist is ready to initiate a new antipsychotic medication, and would consider using either ziprasidone or olanzapine as an appropriate therapy.
• Male and female patients who meet all criteria listed below are eligible to be enrolled in this study:
• Diagnosed with schizophrenia
• Willing to provide information on at least one alternate contact person for study staff to contact regarding patient's whereabouts, should the patient be lost-to-follow-up over the course of the study

Exclusion criteria

• Progressive fatal disease of a life expectancy which prohibits them from participating in a one year research study
• Previously randomized to study medication and enrolled in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)