Clinical trial NCT00418171: Large Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac)
Official title: An International, Multicenter, Large Simple Trial (LST) To Compare The Cardiovascular Safety Of Ziprasidone And Olanzapine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-04
Enrollment: 18239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality within 12 months.
Secondary outcomes:
measure: To estimate the relative incidence among users of ziprasidone and olanzapine of all-cause mortality, mortality due to suicide, cardiovascular mortality, mortality due to sudden death
timeFrame: During the year observation period
measure: To estimate the relative incidence among users of ziprasidone and olanzapine of all-cause hospitalization, hospitalization for arrhythmia, myocardial infarction, or diabetic ketoacidosis
timeFrame: During the year observation period
measure: The rate of discontinuation of randomized treatment.
timeFrame: During the year observation period
Other outcomes:
Locations:
city: San Bernardino
country: United States
facility: Pfizer Investigational Site
state: California
city: Aiea
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Schaumburg
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Grants Pass
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Whitehall
country: United States
facility: Pfizer Investigational Site
state: West Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Fleischhacker WW, Kane JM, Geier J, Karayal O, Kolluri S, Eng SM, Reynolds RF, Strom BL. Completed and attempted suicides among 18,154 subjects with schizophrenia included in a large simple trial. J Clin Psychiatry. 2014 Mar;75(3):e184-90. doi: 10.4088/JCP.13m08563.
citation: Kolitsopoulos FM, Strom BL, Faich G, Eng SM, Kane JM, Reynolds RF. Lessons learned in the conduct of a global, large simple trial of treatments indicated for schizophrenia. Contemp Clin Trials. 2013 Mar;34(2):239-47. doi: 10.1016/j.cct.2012.12.001. Epub 2012 Dec 12.
citation: Strom BL, Eng SM, Faich G, Reynolds RF, D'Agostino RB, Ruskin J, Kane JM. Comparative mortality associated with ziprasidone and olanzapine in real-world use among 18,154 patients with schizophrenia: The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC). Am J Psychiatry. 2011 Feb;168(2):193-201. doi: 10.1176/appi.ajp.2010.08040484. Epub 2010 Nov 1.