Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In Schizophrenia Or Schizoaffective Disorder - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00137020

Purpose

The primary objective is to compare effectiveness of ziprasidone treatment to current treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric Rating Scale (BPRS) scores versus baseline

Condition	Intervention	Phase
Schizophrenia Psychotic Disorders	Drug: ziprasidone	Phase IV

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center Study to Examine The Clinical Effects of Cross Titration of Antipsychotics With Ziprasidone in Subjects With Schizophrenia or Schizoaffective Disorder

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score

Secondary Outcome Measures:

Change From Baseline In Clinical Global Impression Severity (CGI-S)
Clinical Global Impression Improvement (CGI-I)
Change From Baseline In Positive and Negative Syndrome Scale (PANSS) Total
Change from baseline in scores on the Montgomery-Asberg Depression Rating Scale (MADRS)
Change from baseline in scores on the MADRS Without Items 4, 5
Change from baseline in Global Assessment of Functioning (GAF)
Change From Baseline In Drug Attitude Inventory (DAI)
Change From Baseline In Weight
Change From Baseline In Prolactin And Lipid Levels
Change From Baseline in Modified Simpson Angus Scale (m-SAS) Total Score
Change From Baseline in Barnes Akathisia Scale (BAS)
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)— Movement Ratings Total Score
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)— Global Judgment Of Severity Total Score

Estimated Enrollment:	294
Study Start Date:	November 2004
Estimated Study Completion Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Primary diagnosis of schizophrenia or schizoaffective disorder, using DSM-IV criteria.
Currently receiving either haloperidol, olanzapine or risperidone within -/+ 25% of the recommended daily dose (as delineated by the medication's package insert

Exclusion Criteria:

Resistance to conventional antipsychotic drugs
With antipsychotic agents other than olanzapine, risperidone or haloperidol at start of treatment regimen within 12 hours prior to first dose of study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137020

Show 28 Study Locations

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

Study ID Numbers:	A1281117
Study First Received:	August 26, 2005
Last Updated:	August 11, 2006
ClinicalTrials.gov Identifier:	NCT00137020
Health Authority:	Turkey: Ministry of Health

Study placed in the following topic categories:

Schizophrenia
Dopamine
Mental Disorders
Psychotic Disorders

Ziprasidone
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

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

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009