A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese Patients

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00645372
First received: March 24, 2008
Last updated: April 7, 2008
Last verified: April 2008
  Purpose

The purpose of this study is to compare the efficacy and safety of ziprasidone and risperidone for the treatment of schizophrenia in Chinese patients


Condition Intervention Phase
Schizophrenia
Drug: Risperidone
Drug: Ziprasidone
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: A Six Week, Multicenter, Double Blind, Double-Dummy, Parallel, Comparative Study To Compare The Efficacy, Safety And Tolerability Of Ziprasidone With Risperidone In The Treatment Of Chinese Subjects With Acute Exacerbation Of Schizophrenia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events, laboratory test changes, movement disorder scale scores [ Time Frame: Weeks 1, 2, 4, and 6 ] [ Designated as safety issue: Yes ]
  • Change from baseline in PANSS negative subscale score [ Time Frame: Weeks 1, 2, 4, and 6 ] [ Designated as safety issue: No ]
  • Change from baseline in PANSS general psychopathology subscale score [ Time Frame: Weeks 1, 2, 4, and 6 ] [ Designated as safety issue: No ]
  • PANSS responder rate [ Time Frame: Weeks 1, 2, 4 and 6 ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Severity (CGI-S) score [ Time Frame: Baseline and Weeks 1, 2, 4, and 6 ] [ Designated as safety issue: No ]
  • Change from baseline in Brief Psychiatric Rating Scale derived (BPRSd) score [ Time Frame: Weeks 1, 2, 4, and 6 ] [ Designated as safety issue: No ]
  • Change from baseline in PANSS positive subscale score [ Time Frame: Weeks 1, 2, 4, and 6 ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Improement (CGI-I) score [ Time Frame: Weeks 1, 2, 4, and 6 ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: July 2004
Study Completion Date: May 2005
Arms Assigned Interventions
Active Comparator: A Drug: Risperidone
Oral risperidone capsules 1 and 2 mg; doses were 1 mg once daily on Days 1-2, 2 mg once daily on Days 3-4, 3 mg once daily on Days 5-7, and 1, 2, or 3 mg twice daily during Weeks 2-6
Experimental: B Drug: Ziprasidone
Oral ziprasidone capsules 40, 60, and 80 mg; doses were 40 mg twice daily on Days 1-2, 60 mg twice daily on Days 3-7, and 40, 60, or 80 mg twice daily during Weeks 2-6

  Eligibility

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

Inclusion Criteria:

  • Hospitalized patients with schizophrenia
  • Miminum PANSS score of 60 when randomized

Exclusion Criteria:

  • Planned, regular use of antipsyhotics within 1 week of randomization
  • Previous treatment with risperidone that resulted in intolerance or lack of response to risperidone
  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: NCT00645372

Locations
China
Pfizer Investigational Site
Beijing, China, 100083
Pfizer Investigational Site
Beijing, China, 100088
Pfizer Investigational Site
Guangzhou, China, 510370
Pfizer Investigational Site
Nanjing, China, 210029
Pfizer Investigational Site
Shanghai, China, 200030
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: NCT00645372     History of Changes
Other Study ID Numbers: A1281115
Study First Received: March 24, 2008
Last Updated: April 7, 2008
Health Authority: China: Ministry of Health

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 October 01, 2014