A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia

This study has been terminated.
(This study was terminated on November 20, 2003 because of poor recruitment. This study was not terminated due to safety/efficacy.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00645515
First received: March 20, 2008
Last updated: April 25, 2008
Last verified: April 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:


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
Experimental: Arm A 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.
Other Name: Geodon, Zeldox
Active Comparator: Arm B 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
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, see Learn About Clinical Studies.

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

Locations
Spain
Pfizer Investigational Site
Bilbao, Vizcaya, Spain, 48010
Pfizer Investigational Site
Getxo, Vizcaya, Spain, 48990
Pfizer Investigational Site
Madrid, Spain, 28007
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 18, 2014