NCT00418171

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,239

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

October 26, 2009

Status Verified

October 1, 2009

First QC Date

January 3, 2007

Last Update Submit

October 23, 2009

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • 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

    During the year observation period

  • To estimate the relative incidence among users of ziprasidone and olanzapine of all-cause hospitalization, hospitalization for arrhythmia, myocardial infarction, or diabetic ketoacidosis

    During the year observation period

  • The rate of discontinuation of randomized treatment.

    During the year observation period

Interventions

ZiprasidoneDRUG
OlanzapineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

San Bernardino, California, United States

Location

Pfizer Investigational Site

‘Aiea, Hawaii, United States

Location

Pfizer Investigational Site

Schaumburg, Illinois, United States

Location

Pfizer Investigational Site

Grants Pass, Oregon, United States

Location

Pfizer Investigational Site

White Hall, West Virginia, United States

Location

Related Publications (3)

  • 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.

    PMID: 24717389DERIVED

  • 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.

    PMID: 23246610DERIVED

  • 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.

    PMID: 21041245DERIVED

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

ziprasidoneOlanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 4, 2007

Study Start

February 1, 2002

Study Completion

April 1, 2007

Last Updated

October 26, 2009

Record last verified: 2009-10

Locations

US(5)