Status:
COMPLETED
Kahn Study; Investigation Of The Efficacy Of Ziprasidone Versus Olanzapine In The Management Of Recent-Onset Psychosis; A Flexible-Dose, Parallel Group, Double-Blind Study
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
18-40 years
Phase:
PHASE3
Brief Summary
This study intends to compare novel antipsychotics ziprasidone and olanzapine, to confirm the findings of an open study -where stable patients receiving olanzapine switched to ziprasidone- which showe...
Eligibility Criteria
Inclusion
- Duration of illness \< 5 years (according to DSM-IV and onset first psychotic episode); CGI severity score \> 4 (moderately ill)
- maximum exposure to antipsychotic treatment of =\< 16 weeks.
Exclusion
- Concurrent treatment with antipsychotic agents =\< 12 hours prior to randomization
- for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and randomization
- Treatment with antidepressants or mood stabilizers =\< 7 days of randomization
- for MAOIs and moclobemide this period must =\< 2 weeks
- for fluoxetine =\< 5 weeks
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00145444
Start Date
March 1 2003
End Date
November 1 2005
Last Update
February 21 2021
Active Locations (7)
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1
Pfizer Investigational Site
Antwerp, Belgium, B-2060
2
Pfizer Investigational Site
Duffel, Belgium, B-2570
3
Pfizer Investigational Site
Kortenberg, Belgium, B-3070
4
Pfizer Investigational Site
Ermelo, Netherlands, NL-3851 PB