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

Schizophrenia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145444
• Other study ID #: A1281006
• Status: Completed
• Phase: Phase 3
• Start date: March 2003
• Est. completion date: November 2005

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Drug:
• olanzapine

• ziprasidone

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Antwerpen
Belgium	Pfizer Investigational Site	Duffel
Belgium	Pfizer Investigational Site	Kortenberg
Netherlands	Pfizer Investigational Site	Ermelo
Netherlands	Pfizer Investigational Site	Groningen
Netherlands	Pfizer Investigational Site	Nijmegen
Netherlands	Pfizer Investigational Site	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	- 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

External Links

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