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
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Psychotic Disorders
Intervention: olanzapine (Drug); ziprasidone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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 showed maintenance of clinical effect with improvements in all domains of
cognitive function at 6 weeks (Daniel, 1999). Direct comparison of the two agents in a
well-controlled double-blind fashion will allow an evaluation of the effect on cognitive
function in the short and long-term management of patients with recent-onset schizophrenia,
schizoaffective and schizophreniform disorder.
Clinical Details
Official title: A Multicenter, Double-Blind, Randomized Trial Of Ziprasidone (80 - 160 Mg) Versus Olanzapine (10 - 20 Mg) In Patients With Recent-Onset Schizophrenia, Schizoaffective And Schizophreniform Disorder.
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: The effect on cognitive function of ziprasidone and olanzapine in the management of recent-onset psychosis, measured as the difference in efficacy in a 8 week period from the baseline visit to the end of week 8 visit.
Secondary outcome: - to demonstrate effect on cognitive function of ziprasidone and olanzapine in the management of recent-onset psychosis, measured as the difference in efficacy over a 24-week and one year period from baseline visit to the end of week 24 and week 52 visit
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Pfizer Investigational Site, Kortenberg B-3070, Belgium
Pfizer Investigational Site, Duffel B-2570, Belgium
Pfizer Investigational Site, Antwerpen B-2060, Belgium
Pfizer Investigational Site, UTRECHT 3584 CX, Netherlands
Pfizer Investigational Site, GRONINGEN NL-9713 GZ, Netherlands
Pfizer Investigational Site, Ermelo NL-3851 PB, Netherlands
Pfizer Investigational Site, Nijmegen NL-6525 GC, Netherlands
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting
Starting date: March 2003
Ending date: November 2005
Last updated: December 28, 2006
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