Ziprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes

Phase 4 Completed 77 enrolled Veterans Medical Research Foundation National Institute of Mental Health (NIMH) · collab Pfizer · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.

Timeline

Start: 2006-06
Primary completion: 2009-12
Completion: 2009-12

Outcome

Missed primary endpoint

registry analysis (unspecified test); Control vs Switch; p = 0.228; t-test, 2 sided NCT00338949 ↗

registry analysis (unspecified test); Control vs Switch; p = 0.958; t-test, 2 sided NCT00338949 ↗

Publications

Background McEvoy JP, Meyer JM, Goff DC, Nasrallah HA, Davis SM, Sullivan L, Meltzer HY, Hsiao J, Scott Stroup T, Lieberman JA. Prevalence of the metabolic syndrome in patients with schizophrenia: baseline results from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial and comparison with national estimates from NHANES III. Schizophr Res. 2005 Dec 1;80(1):19-32. doi: 10.1016/j.schres.2005.07.014. Epub 2005 Aug 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ziprasidone	Small molecule	200 mg	—
Comparator	Olanzapine	Small molecule	—	—
Comparator	Risperidone	Other / unclassified	—	—