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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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:

MedlinePlus related topics: Mental Disorders Psychotic Disorders Schizophrenia

Drug Information available for: Ziprasidone hydrochloride Olanzapine Ziprasidone Ziprasidone mesylate

U.S. FDA Resources

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
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:

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

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Grootens KP, van Veelen NM, Peuskens J, Sabbe BG, Thys E, Buitelaar JK, Verkes RJ, Kahn RS. Ziprasidone vs olanzapine in recent-onset schizophrenia and schizoaffective disorder: results of an 8-week double-blind randomized controlled trial. Schizophr Bull. 2011 Mar;37(2):352-61. Epub 2009 Jun 19.

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

Additional relevant MeSH terms:

Psychotic Disorders
Mental Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Olanzapine
Ziprasidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on February 07, 2012