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.

Condition	Intervention	Phase
Schizophrenia Psychotic Disorders	Drug: olanzapine  Drug: ziprasidone	Phase III

Further Study Details: 

Primary Outcomes: 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 Outcomes: - 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
Expected Total Enrollment:  100

Ages Eligible for Study:  18 Years   -   40 Years,  Genders Eligible for Study:  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

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A1281006
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00145444
Health Authority: Netherlands: Independent Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-13