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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00645372

Enrollment

242

Registered

2008-03-27

Start date

2004-07-31

Completion date

2005-05-31

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief 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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026