CClinicalTrials.gg
CompletedNCT00645372Updated Feb 21, 2021

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

A Phase 3 interventional study of Risperidone and Ziprasidone in Schizophrenia, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 5 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-21.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
242
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Schizophrenia

Browse trials for

03

In context

Schizophrenia

3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.

This study's enrollment of 242 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
242 participants (actual)

Study arms

  • Active comparator
    A

    Drug: Risperidone

  • Experimental
    B

    Drug: Ziprasidone

Interventions

  • DrugRisperidone

    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

  • DrugZiprasidone

    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

06

What researchers measure

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

07

Study locations

5 sites
  • Pfizer Investigational Site
    Beijing, 100083, China
  • Pfizer Investigational Site
    Beijing, 100088, China
  • Pfizer Investigational Site
    Guangzhou, 510370, China
  • Pfizer Investigational Site
    Nanjing, 210029, China
  • Pfizer Investigational Site
    Shanghai, 200030, China
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00645372
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party
Sponsor
First posted
Mar 27, 2008
Start date
Jul 2004
Completion
May 2005
Last update
Feb 21, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion