Status:
TERMINATED
Ziprasidone And Olanzapine's Outcomes In Mania
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Acute Mania
Bipolar Disorder, Manic
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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, safe...
Eligibility Criteria
Inclusion
- Have a primary diagnosis of Bipolar I Disorder, current episode manic (DSM-IV 296.4x) or mixed (DSM-IV296.6x) as determined by a structured clinical interview (Mini International Neuropsychiatric Interview (MINI)) at screening.
- A minimum score of 20 on the YMRS (Youngs Mania Rating Scale).
Exclusion
- Have a diagnosis of learning disability or organic brain syndrome.
- Have a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00329108
Start Date
November 1 2006
End Date
January 1 2008
Last Update
March 29 2021
Active Locations (19)
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1
Pfizer Investigational Site
Aachen, Germany, 52074
2
Pfizer Investigational Site
Augsburg, Germany, 86156
3
Pfizer Investigational Site
Freiburg im Breisgau, Germany, 79104
4
Pfizer Investigational Site
Athens, Greece, 124 62