SchizophreniaPhase 3NCT00645515
A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia
A Phase 3 study testing Ziprasidone and Risperidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 3 sites in Spain.
Trial summary
The purpose of this study is to compare the safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Ziprasidone and Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesSpain
- Study dates
- Jun 2003to Dec 2003
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia
- CGI-S score of 4 or less at baseline
Who cannot join
- Concurrent antipsychotic treatment
- Treatment with antidepressants or mood stabilizers within 2 weeks of randomization
- Acute exacerbation of schizophrenia within 3 months of baseline
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Pfizer Investigational Site
Bilbao, Vizcaya, 48010
Pfizer Investigational Site
Getxo, Vizcaya, 48990
Pfizer Investigational Site
Madrid, 28007
About this study
Official title: Ziprasidone Versus Risperidone In The Treatment Of Chronic Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study
The purpose of this study is to compare the safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy.
- Conditions
- Schizophrenia
- Being tested
- Ziprasidone, Risperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiprasidoneDrug
Also called Geodon, Zeldox
Initial dose of 40 mg capsules twice daily on Days 1-3; dose could be flexibly changed within the range of 40 to 80 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
RisperidoneDrug
Initial dose of 10 mg once daily on Days 1-3; dose could be flexibly changed within the range of 3 to 9 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: Ziprasidone |
| Arm B | Active comparator | Not described Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Simpson-Angus Scale (SAS) scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Measured: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Secondary outcomes (11)
Change from baseline in cognitive function assessment at Weeks 4 and 24
Measured: Day 1 and Weeks 4 and 24
Change from baseline in Patient Preference Scale (PPS) at Weeks 4, 10, 12, 16, and 24
Measured: Day 1 and Weeks 4, 10, 12, 16, and 24
Changes in Sexual Functioning Questionnaire at Weeks 1, 4, 12, 16, and 24
Measured: Day 1 and Weeks 1, 4, 12, 16, and 24
Change from baseline in Cuestionario Sevilla at Weeks 1, 4, 12, 16, and 24
Measured: Day 1 and Weeks 1, 4, 12, 16, and 24
Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores at Weeks 3, 4, 6, 10, 12, 16, and 24
Measured: Day 1 and Weeks 3, 4, 6, 10, 12, 16, and 24
Laboratory tests and electrocardiogram at Week 24
Measured: Screening and Week 24
Adverse events on Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Measured: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Measured: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Clinical Global Impressions-Improvement (CGI-I) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Measured: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores and negative subscale scores at Weeks 4, 10, 12, 16, and 24
Measured: Day 1 and Weeks 4, 10, 12, 16, and 24
Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movements Scale (AIMS) scores at Weeks 4, 10, 12, 16, and 24
Measured: Day 1 and Weeks 4, 10, 12, 16, and 24
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 startJun 2003
- Study completionDec 2003
Why it stopped: This study was terminated on November 20, 2003 because of poor recruitment. This study was not terminated due to safety/efficacy.
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
- 240 participants (estimated)
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
- NCT00645515
- Sponsor's protocol ID
- A1281065
- Status last verified
- Feb 2021
- First submitted
- 20 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
- Ziprasidone Versus Risperidone In The Treatment Of Chronic Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study
- ClinicalTrials.gov ID
- NCT00645515
- Acronym / sponsor ID
- A1281065
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated on November 20, 2003 because of poor recruitment. This study was not terminated due to safety/efficacy.
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Dec 2003 (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 safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Ziprasidone |
| Arm B | Active comparator | Drug: Risperidone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of schizophrenia
- CGI-S score of 4 or less at baseline
Key exclusion criteria (3 listed)
- Concurrent antipsychotic treatment
- Treatment with antidepressants or mood stabilizers within 2 weeks of randomization
- Acute exacerbation of schizophrenia within 3 months of baseline
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 |
|---|---|---|
| ZiprasidoneAlso: Geodon, ZeldoxInitial dose of 40 mg capsules twice daily on Days 1-3; dose could be flexibly changed within the range of 40 to 80 mg twice daily for the remainder of the study; treatment duration was 24 weeks. | Drug | Arm A |
| RisperidoneInitial dose of 10 mg once daily on Days 1-3; dose could be flexibly changed within the range of 3 to 9 mg twice daily for the remainder of the study; treatment duration was 24 weeks. | Drug | Arm B |
Primary outcome
Change from baseline in Simpson-Angus Scale (SAS) scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Time frame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
11 secondary outcomes
Change from baseline in cognitive function assessment at Weeks 4 and 24
Time frame: Day 1 and Weeks 4 and 24
Change from baseline in Patient Preference Scale (PPS) at Weeks 4, 10, 12, 16, and 24
Time frame: Day 1 and Weeks 4, 10, 12, 16, and 24
Changes in Sexual Functioning Questionnaire at Weeks 1, 4, 12, 16, and 24
Time frame: Day 1 and Weeks 1, 4, 12, 16, and 24
Change from baseline in Cuestionario Sevilla at Weeks 1, 4, 12, 16, and 24
Time frame: Day 1 and Weeks 1, 4, 12, 16, and 24
Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores at Weeks 3, 4, 6, 10, 12, 16, and 24
Time frame: Day 1 and Weeks 3, 4, 6, 10, 12, 16, and 24
Laboratory tests and electrocardiogram at Week 24
Time frame: Screening and Week 24
Adverse events on Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Time frame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Time frame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Clinical Global Impressions-Improvement (CGI-I) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Time frame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores and negative subscale scores at Weeks 4, 10, 12, 16, and 24
Time frame: Day 1 and Weeks 4, 10, 12, 16, and 24
Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movements Scale (AIMS) scores at Weeks 4, 10, 12, 16, and 24
Time frame: Day 1 and Weeks 4, 10, 12, 16, and 24
Results and safety
The study was stopped early (reason given: This study was terminated on November 20, 2003 because of poor recruitment. This study was not terminated due to safety/efficacy.). Results are not available in the source record.
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
3 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 Ziprasidone and Risperidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 3 sites in Spain.
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 3 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: stopped early, 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 3 sites in Spain. 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 was stopped early (reason given: This study was terminated on November 20, 2003 because of poor recruitment. This study was not terminated due to safety/efficacy.). Results are not available in the source record.
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 Simpson-Angus Scale (SAS) scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24 (time frame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24). 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.