SchizophreniaPhase 3MOZARTNCT00649844
A Study Comparing the Efficacy and Tolerability of Ziprasidone vs. Clozapine for the Treatment of Schizophrenia in Patients Who Continue to Have Symptoms on or Cannot Tolerate Other Antipsychotic Drugs
A Phase 3 study testing Clozapine and Ziprasidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 22 sites in 2 countries.
Trial summary
The purpose of this study is to compare the efficacy and safety of ziprasidone and clozapine in schizophrenic patients who are resistant and/or intolerant to antipsychotic treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Clozapine and Ziprasidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Jan 2003to Sep 2004
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CGI - S ≥4
- PANSS ≥ 80
- Inpatients or outpatients
Who cannot join
- Patients with a history of myeloproliferative diseases, history of granulocytopenia, agranulocytosis due to a drug
- Diagnosis of substance dependence within previous 3 months using DSM-IV criteria
- History of seizure
- Organic mental disease, including mental retardation or epilepsy
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
Italy21 sites
Pfizer Investigational Site
Bari, 70124
Pfizer Investigational Site
Bassano del Grappa, Vicenza, 36061
Pfizer Investigational Site
Brescia, 25100
Pfizer Investigational Site
Cagliari, 09045
Pfizer Investigational Site
Cagliari, 09124
Pfizer Investigational Site
Catania, 95123
Pfizer Investigational Site
Città di Castello, Perugia, 06012
Pfizer Investigational Site
Florence, 50134
Pfizer Investigational Site
Guardiagrele (CH), 66016
Pfizer Investigational Site
Messina, 98100
Pfizer Investigational Site
Montichiari (brescia), 25018
Pfizer Investigational Site
Naples, 80131
Pfizer Investigational Site
Parma, 43100
Pfizer Investigational Site
Reggio Calabria, 89100
Pfizer Investigational Site
Roma, 00135
Pfizer Investigational Site
Roma, 00137
Pfizer Investigational Site
Sassari, 07100
Pfizer Investigational Site
Siena, 53100
Pfizer Investigational Site
Torino, 10126
Pfizer Investigational Site
Trieste, 34126
Pfizer Investigational Site
Verona, 37126
Location not given1 site
Pfizer Investigational Site
About this study
Official title: Double Blind, Double-Dummy Multicenter, Parallel Group Comparison Of The Efficacy And The Tolerability Of Ziprasidone Vs. Clozapine In Schizophrenic Patients Who Are Refractory And/Or Intolerant To Antipsychotic Therapy
The purpose of this study is to compare the efficacy and safety of ziprasidone and clozapine in schizophrenic patients who are resistant and/or intolerant to antipsychotic treatment
- Conditions
- Schizophrenia
- Being tested
- Clozapine, Ziprasidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClozapineDrug
Clozapine 25 or 100 mg tablets. Patients were initially titrated over the first 10 days to 300 mg/day and remained at this dose for 1 week. Thereafter, the dose could be varied between 250 and 600 mg/day based on response and tolerability for a total treatment duration of 18 weeks
ZiprasidoneDrug
Also called Geodon, Zeldox
Ziprasidone 40, 60, or 80 mg capsules. Patients were initially titrated over the first 3 days to 80 mg/day, which could subsequently be increased to between 80 and 160 mg/day based on response and tolerability for a total treatment duration of 18 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Clozapine |
| 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 to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores
Measured: Until Final Visit (within 18 weeks)
Secondary outcomes (16)
Proportion of responders, based on change from baseline to endpoint in PANSS total score
Measured: Until Final Visit (within 18 weeks)
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores
Measured: Baseline and weekly from Weeks 1-18
Time to discontinuation
Measured: Up to 18 weeks
Change from baseline to endpoint in cognitive function assessments, including Rey serial verbal learning test, Stroop Color Word test, and Trail Making Test
Measured: Baseline and Weeks 12 and 18
Change from baseline to endpoint in Global Assessment of Functioning (GAF) scores
Measured: Baseline and Week 8, 12, and 18
Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores
Measured: Baseline and Weeks 4, 8, 12, and 18
Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores
Measured: Screening and Weeks 1, 8, 12, and 18
Change from baseline to endpoint in PANSS subscale scores
Measured: Baseline and weekly from Weeks 1-18
Adverse events
Measured: Weekly from Weeks 1-18
Change from baseline to endpoint in Calgary Depression Scale (CDSS) scores
Measured: Baseline and Weeks 8, 12, and 18
Change from baseline in Caregiver Activity Survey (CAS)
Measured: Screening and Weeks 1, 8, 12, and 18
Change from baseline in laboratory tests
Measured: Screening and weekly from Weeks 1-18
Change from baseline in electrocardiogram
Measured: Screening and Weeks 1, 8, 12, and 18
Change from baseline in movement disorder rating scales, including Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale, and Simpson-Angus Scale
Measured: Baseline and Weeks 1, 8, 12, and 18
Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scores
Measured: Baseline and weekly from Weeks 1-18
Change from baseline to endpoint in Patient Preference Scale (PPS) scores
Measured: Screening and Weeks 1, 8, 12, and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJan 2003
- Study completionSep 2004
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
- 147 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
- NCT00649844
- Sponsor's protocol ID
- A1281039
- Acronym
- MOZART
- Status last verified
- Feb 2021
- First submitted
- 28 Mar 2008
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
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
- Double Blind, Double-Dummy Multicenter, Parallel Group Comparison Of The Efficacy And The Tolerability Of Ziprasidone Vs. Clozapine In Schizophrenic Patients Who Are Refractory And/Or Intolerant To Antipsychotic Therapy
- ClinicalTrials.gov ID
- NCT00649844
- Acronym / sponsor ID
- MOZART / A1281039
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Sep 2004 (actual)
- First posted
- 1 Apr 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 clozapine in schizophrenic patients who are resistant and/or intolerant to antipsychotic treatment
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: Clozapine |
| B | Experimental | Drug: Ziprasidone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CGI - S ≥4
- PANSS ≥ 80
- Inpatients or outpatients
Key exclusion criteria (4 listed)
- Patients with a history of myeloproliferative diseases, history of granulocytopenia, agranulocytosis due to a drug
- Diagnosis of substance dependence within previous 3 months using DSM-IV criteria
- History of seizure
- Organic mental disease, including mental retardation or epilepsy
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 |
|---|---|---|
| ClozapineClozapine 25 or 100 mg tablets. Patients were initially titrated over the first 10 days to 300 mg/day and remained at this dose for 1 week. Thereafter, the dose could be varied between 250 and 600 mg/day based on response and tolerability for a total treatment duration of 18 weeks | Drug | A |
| ZiprasidoneAlso: Geodon, ZeldoxZiprasidone 40, 60, or 80 mg capsules. Patients were initially titrated over the first 3 days to 80 mg/day, which could subsequently be increased to between 80 and 160 mg/day based on response and tolerability for a total treatment duration of 18 weeks | Drug | B |
Primary outcome
Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores
Time frame: Until Final Visit (within 18 weeks)
16 secondary outcomes
Proportion of responders, based on change from baseline to endpoint in PANSS total score
Time frame: Until Final Visit (within 18 weeks)
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scores
Time frame: Baseline and weekly from Weeks 1-18
Time to discontinuation
Time frame: Up to 18 weeks
Change from baseline to endpoint in cognitive function assessments, including Rey serial verbal learning test, Stroop Color Word test, and Trail Making Test
Time frame: Baseline and Weeks 12 and 18
Change from baseline to endpoint in Global Assessment of Functioning (GAF) scores
Time frame: Baseline and Week 8, 12, and 18
Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores
Time frame: Baseline and Weeks 4, 8, 12, and 18
Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores
Time frame: Screening and Weeks 1, 8, 12, and 18
Change from baseline to endpoint in PANSS subscale scores
Time frame: Baseline and weekly from Weeks 1-18
Adverse events
Time frame: Weekly from Weeks 1-18
Change from baseline to endpoint in Calgary Depression Scale (CDSS) scores
Time frame: Baseline and Weeks 8, 12, and 18
Change from baseline in Caregiver Activity Survey (CAS)
Time frame: Screening and Weeks 1, 8, 12, and 18
Change from baseline in laboratory tests
Time frame: Screening and weekly from Weeks 1-18
Change from baseline in electrocardiogram
Time frame: Screening and Weeks 1, 8, 12, and 18
Change from baseline in movement disorder rating scales, including Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale, and Simpson-Angus Scale
Time frame: Baseline and Weeks 1, 8, 12, and 18
Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scores
Time frame: Baseline and weekly from Weeks 1-18
Change from baseline to endpoint in Patient Preference Scale (PPS) scores
Time frame: Screening and Weeks 1, 8, 12, and 18
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
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clozapine and Ziprasidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 22 sites in 2 countries.
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 3 inclusion and 4 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 22 sites in Italy. 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 to endpoint in Positive and Negative Syndrome Scale (PANSS) total scores (time frame: Until Final Visit (within 18 weeks)). 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.