drugset / Trial / NCT00329108

Ziprasidone And Olanzapine's Outcomes In Mania

NCT00329108

Phase 4 Terminated 29 enrolled Viatris Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare the efficacy and tolerability of ziprasidone versus olanzapine in the treatment of acute mania. An open label extension will further evaluate the efficacy, safety, and tolerability of ziprasidone compared with olanzapine. Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on July 30, 2007. Subjects that were enrolled at the time completed the study as per protocol. There were no safety concerns involved in the decision to stop enrollment. The Last Subject Last Visit was January 10, 2008.

Timeline

Start
2006-11
Primary completion
2007-07
Completion
2008-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Olanzapine Small molecule 15 mg
Comparator Olanzapine Small molecule 20 mg
Subject Ziprasidone Small molecule 120 mg
Subject Ziprasidone Small molecule 160 mg