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The primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziprasidone | Drug | |||
| Olanzapine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | San Bernardino | California | United States | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24717389 | Derived | 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. | |
| 23246610 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| During the year observation period |
| The rate of discontinuation of randomized treatment. | During the year observation period |
| ‘Aiea |
| Hawaii |
| United States |
| Pfizer Investigational Site | Schaumburg | Illinois | United States |
| Pfizer Investigational Site | Grants Pass | Oregon | United States |
| Pfizer Investigational Site | White Hall | West Virginia | United States |
| 21041245 | Derived | 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. |
| D006571 | Heterocyclic Compounds |