SchizophreniaPhase 3NCT00645372
A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese Patients
A Phase 3 study testing Risperidone and Ziprasidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 5 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone and Ziprasidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 5 sitesChina
- Study dates
- Jul 2004to May 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients with schizophrenia
- Miminum PANSS score of 60 when randomized
Who cannot join
- Planned, regular use of antipsyhotics within 1 week of randomization
- Previous treatment with risperidone that resulted in intolerance or lack of response to risperidone
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Pfizer Investigational Site
Beijing, 100083
Pfizer Investigational Site
Beijing, 100088
Pfizer Investigational Site
Guangzhou, 510370
Pfizer Investigational Site
Nanjing, 210029
Pfizer Investigational Site
Shanghai, 200030
About this study
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
The purpose of this study is to compare the efficacy and safety of ziprasidone and risperidone for the treatment of schizophrenia in Chinese patients
- Conditions
- Schizophrenia
- Being tested
- Risperidone, Ziprasidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
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
ZiprasidoneDrug
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 group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Risperidone |
| B | Experimental | Not described Receives: Drug: Ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Measured: Week 6
Secondary outcomes (8)
Adverse events, laboratory test changes, movement disorder scale scores
Measured: Weeks 1, 2, 4, and 6
Change from baseline in PANSS negative subscale score
Measured: Weeks 1, 2, 4, and 6
Change from baseline in PANSS general psychopathology subscale score
Measured: Weeks 1, 2, 4, and 6
PANSS responder rate
Measured: Weeks 1, 2, 4 and 6
Clinical Global Impression-Severity (CGI-S) score
Measured: Baseline and Weeks 1, 2, 4, and 6
Change from baseline in Brief Psychiatric Rating Scale derived (BPRSd) score
Measured: Weeks 1, 2, 4, and 6
Change from baseline in PANSS positive subscale score
Measured: Weeks 1, 2, 4, and 6
Clinical Global Impression-Improement (CGI-I) score
Measured: Weeks 1, 2, 4, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startJul 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645372
- Sponsor's protocol ID
- A1281115
- Status last verified
- Feb 2021
- First submitted
- 24 Mar 2008
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00645372
- Acronym / sponsor ID
- A1281115
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- May 2005 (actual)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of ziprasidone and risperidone for the treatment of schizophrenia in Chinese patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Risperidone |
| B | Experimental | Drug: Ziprasidone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalized patients with schizophrenia
- Miminum PANSS score of 60 when randomized
Key exclusion criteria (2 listed)
- Planned, regular use of antipsyhotics within 1 week of randomization
- Previous treatment with risperidone that resulted in intolerance or lack of response to risperidone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisperidoneOral 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 | Drug | A |
| ZiprasidoneOral 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 | Drug | B |
Primary outcome
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: Week 6
8 secondary outcomes
Adverse events, laboratory test changes, movement disorder scale scores
Time frame: Weeks 1, 2, 4, and 6
Change from baseline in PANSS negative subscale score
Time frame: Weeks 1, 2, 4, and 6
Change from baseline in PANSS general psychopathology subscale score
Time frame: Weeks 1, 2, 4, and 6
PANSS responder rate
Time frame: Weeks 1, 2, 4 and 6
Clinical Global Impression-Severity (CGI-S) score
Time frame: Baseline and Weeks 1, 2, 4, and 6
Change from baseline in Brief Psychiatric Rating Scale derived (BPRSd) score
Time frame: Weeks 1, 2, 4, and 6
Change from baseline in PANSS positive subscale score
Time frame: Weeks 1, 2, 4, and 6
Clinical Global Impression-Improement (CGI-I) score
Time frame: Weeks 1, 2, 4, and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risperidone and Ziprasidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.