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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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 1, 2005
Last updated: December 28, 2006
Last verified: December 2006
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 Measures:
  • - 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

Estimated Enrollment: 100
Study Start Date: March 2003
Estimated Study Completion Date: November 2005

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00145444

Pfizer Investigational Site
Antwerpen, Belgium, B-2060
Pfizer Investigational Site
Duffel, Belgium, B-2570
Pfizer Investigational Site
Kortenberg, Belgium, B-3070
Pfizer Investigational Site
Ermelo, Netherlands, NL-3851 PB
Pfizer Investigational Site
Groningen, Netherlands, NL-9713 GZ
Pfizer Investigational Site
Nijmegen, Netherlands, NL-6525 GC
Pfizer Investigational Site
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00145444     History of Changes
Other Study ID Numbers: A1281006
Study First Received: September 1, 2005
Last Updated: December 28, 2006

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents processed this record on August 23, 2017