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
1 other identifier
interventional
242
1 country
5
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started Jul 2004
Shorter than P25 for phase_3 schizophrenia
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 24, 2008
CompletedFirst Posted
Study publicly available on registry
March 27, 2008
CompletedFebruary 21, 2021
February 1, 2021
March 24, 2008
February 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Week 6
Secondary Outcomes (8)
Adverse events, laboratory test changes, movement disorder scale scores
Weeks 1, 2, 4, and 6
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
Clinical Global Impression-Severity (CGI-S) score
Baseline and Weeks 1, 2, 4, and 6
- +3 more secondary outcomes
Study Arms (2)
A
ACTIVE COMPARATORB
EXPERIMENTALInterventions
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
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 Criteria
You may qualify if:
- Hospitalized patients with schizophrenia
- Miminum PANSS score of 60 when randomized
You may not qualify if:
- Planned, regular use of antipsyhotics within 1 week of randomization
- Previous treatment with risperidone that resulted in intolerance or lack of response to risperidone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2008
First Posted
March 27, 2008
Study Start
July 1, 2004
Study Completion
May 1, 2005
Last Updated
February 21, 2021
Record last verified: 2021-02