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Completed

NCT Number: NCT00645372

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risperidone

Drug

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

Ziprasidone

Drug

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

Primary outcomes

  1. Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

    Time frame: Week 6

Secondary outcomes

  1. Adverse events, laboratory test changes, movement disorder scale scores

    Time frame: Weeks 1, 2, 4, and 6

  2. Change from baseline in PANSS negative subscale score

    Time frame: Weeks 1, 2, 4, and 6

  3. Change from baseline in PANSS general psychopathology subscale score

    Time frame: Weeks 1, 2, 4, and 6

  4. PANSS responder rate

    Time frame: Weeks 1, 2, 4 and 6

  5. Clinical Global Impression-Severity (CGI-S) score

    Time frame: Baseline and Weeks 1, 2, 4, and 6

  6. Change from baseline in Brief Psychiatric Rating Scale derived (BPRSd) score

    Time frame: Weeks 1, 2, 4, and 6

  7. Change from baseline in PANSS positive subscale score

    Time frame: Weeks 1, 2, 4, and 6

  8. Clinical Global Impression-Improement (CGI-I) score

    Time frame: Weeks 1, 2, 4, and 6

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
Mar 27, 2008
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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