A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00645515

Purpose

The purpose of this study is to compare the safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy.

Condition	Intervention	Phase
Schizophrenia	Drug: Ziprasidone Drug: Risperidone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Ziprasidone Versus Risperidone In The Treatment Of Chronic Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Ziprasidone hydrochloride Ziprasidone Ziprasidone mesylate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in Simpson-Angus Scale (SAS) scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 [ Time Frame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in cognitive function assessment at Weeks 4 and 24 [ Time Frame: Day 1 and Weeks 4 and 24 ] [ Designated as safety issue: No ]
Change from baseline in Patient Preference Scale (PPS) at Weeks 4, 10, 12, 16, and 24 [ Time Frame: Day 1 and Weeks 4, 10, 12, 16, and 24 ] [ Designated as safety issue: No ]
Changes in Sexual Functioning Questionnaire at Weeks 1, 4, 12, 16, and 24 [ Time Frame: Day 1 and Weeks 1, 4, 12, 16, and 24 ] [ Designated as safety issue: No ]
Change from baseline in Cuestionario Sevilla at Weeks 1, 4, 12, 16, and 24 [ Time Frame: Day 1 and Weeks 1, 4, 12, 16, and 24 ] [ Designated as safety issue: No ]
Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores at Weeks 3, 4, 6, 10, 12, 16, and 24 [ Time Frame: Day 1 and Weeks 3, 4, 6, 10, 12, 16, and 24 ] [ Designated as safety issue: No ]
Laboratory tests and electrocardiogram at Week 24 [ Time Frame: Screening and Week 24 ] [ Designated as safety issue: Yes ]
Adverse events on Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 [ Time Frame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 ] [ Designated as safety issue: Yes ]
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 [ Time Frame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 ] [ Designated as safety issue: No ]
Clinical Global Impressions-Improvement (CGI-I) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 [ Time Frame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 ] [ Designated as safety issue: No ]
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores and negative subscale scores at Weeks 4, 10, 12, 16, and 24 [ Time Frame: Day 1 and Weeks 4, 10, 12, 16, and 24 ] [ Designated as safety issue: No ]
Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movements Scale (AIMS) scores at Weeks 4, 10, 12, 16, and 24 [ Time Frame: Day 1 and Weeks 4, 10, 12, 16, and 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	240
Study Start Date:	June 2003
Study Completion Date:	December 2003

Arms	Assigned Interventions
Arm A: Experimental	Drug: Ziprasidone Initial dose of 40 mg capsules twice daily on Days 1-3; dose could be flexibly changed within the range of 40 to 80 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
Arm B: Active Comparator	Drug: Risperidone Initial dose of 10 mg once daily on Days 1-3; dose could be flexibly changed within the range of 3 to 9 mg twice daily for the remainder of the study; treatment duration was 24 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of schizophrenia
CGI-S score of 4 or less at baseline

Exclusion Criteria:

Concurrent antipsychotic treatment
Treatment with antidepressants or mood stabilizers within 2 weeks of randomization
Acute exacerbation of schizophrenia within 3 months of baseline

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645515

Locations

Spain
Pfizer Investigational Site
MADRID, Spain, 28007
Spain, VIZCAYA
Pfizer Investigational Site
GETXO, VIZCAYA, Spain, 48990
Pfizer Investigational Site
BILBAO, VIZCAYA, Spain, 48010

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

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

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1281065
Study First Received:	March 20, 2008
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00645515 History of Changes
Health Authority:	Spain: Spanish Agency For Medicinal Products And Medical Devices

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Risperidone
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Serotonin

Schizophrenia
Dopamine
Mental Disorders
Psychotic Disorders
Dopamine Agents
Ziprasidone
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions

Schizophrenia
Serotonin Antagonists
Serotonin Agents
Mental Disorders
Therapeutic Uses
Dopamine Agents
Ziprasidone
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 10, 2009