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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00145444
First Posted: September 5, 2005
Last Update Posted: January 1, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145444


Locations
Belgium
Pfizer Investigational Site
Antwerpen, Belgium, B-2060
Pfizer Investigational Site
Duffel, Belgium, B-2570
Pfizer Investigational Site
Kortenberg, Belgium, B-3070
Netherlands
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00145444     History of Changes
Other Study ID Numbers: A1281006
First Submitted: September 1, 2005
First Posted: September 5, 2005
Last Update Posted: January 1, 2007
Last Verified: December 2006

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Olanzapine
Ziprasidone
Antiemetics
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