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 - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00145444

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 III

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Olanzapine Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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.

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

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145444

Locations

Belgium
Pfizer Investigational Site
Kortenberg, Belgium, B-3070
Pfizer Investigational Site
Duffel, Belgium, B-2570
Pfizer Investigational Site
Antwerpen, Belgium, B-2060
Netherlands
Pfizer Investigational Site
Nijmegen, Netherlands, NL-6525 GC
Pfizer Investigational Site
GRONINGEN, Netherlands, NL-9713 GZ
Pfizer Investigational Site
Ermelo, Netherlands, NL-3851 PB
Pfizer Investigational Site
UTRECHT, Netherlands, 3584 CX

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	A1281006
Study First Received:	September 1, 2005
Last Updated:	December 28, 2006
ClinicalTrials.gov Identifier:	NCT00145444
Health Authority:	Netherlands: Independent Ethics Committee

Study placed in the following topic categories:

Schizophrenia
Dopamine
Mental Disorders
Olanzapine

Psychotic Disorders
Ziprasidone
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009