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

February 18, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

242

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • 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
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Time Frame: Week 6
Week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events, laboratory test changes, movement disorder scale scores
Time Frame: Weeks 1, 2, 4, and 6
Weeks 1, 2, 4, and 6
Change from baseline in PANSS negative subscale score
Time Frame: Weeks 1, 2, 4, and 6
Weeks 1, 2, 4, and 6
Change from baseline in PANSS general psychopathology subscale score
Time Frame: Weeks 1, 2, 4, and 6
Weeks 1, 2, 4, and 6
PANSS responder rate
Time Frame: Weeks 1, 2, 4 and 6
Weeks 1, 2, 4 and 6
Clinical Global Impression-Severity (CGI-S) score
Time Frame: Baseline and Weeks 1, 2, 4, and 6
Baseline and Weeks 1, 2, 4, and 6
Change from baseline in Brief Psychiatric Rating Scale derived (BPRSd) score
Time Frame: Weeks 1, 2, 4, and 6
Weeks 1, 2, 4, and 6
Change from baseline in PANSS positive subscale score
Time Frame: Weeks 1, 2, 4, and 6
Weeks 1, 2, 4, and 6
Clinical Global Impression-Improement (CGI-I) score
Time Frame: Weeks 1, 2, 4, and 6
Weeks 1, 2, 4, and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1281115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Risperidone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe