A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese Patients
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00645372
Collaborator
(none)
242
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Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
242 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official 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
Study Start Date
:
Jul 1, 2004
Actual Study Completion Date
:
May 1, 2005
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score [Week 6]
Secondary Outcome Measures
- 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]
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Beijing | China | 100083 | |
| 2 | Pfizer Investigational Site | Beijing | China | 100088 | |
| 3 | Pfizer Investigational Site | Guangzhou | China | 510370 | |
| 4 | Pfizer Investigational Site | Nanjing | China | 210029 | |
| 5 | Pfizer Investigational Site | Shanghai | China | 200030 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00645372
Other Study ID Numbers:
- A1281115
First Posted:
Mar 27, 2008
Last Update Posted:
Feb 21, 2021
Last Verified:
Feb 1, 2021