SchizophreniaPhase 4NCT00137020
Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In Schizophrenia Or Schizoaffective Disorder
A Phase 4 study testing ziprasidone in people with Schizophrenia and Psychotic Disorders, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 27 sites in 9 countries.
Trial summary
The primary objective is to compare effectiveness of ziprasidone treatment to current treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric Rating Scale (BPRS) scores versus baseline Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- What is being tested?
- ziprasidone
- How many people
- 294 participants
- Where
- 27 sitesin 9 countries
- Study dates
- Nov 2004to Apr 2006
- Phase
- Phase 4
- 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
- Primary diagnosis of schizophrenia or schizoaffective disorder, using DSM-IV criteria.
- Currently receiving either haloperidol, olanzapine or risperidone within -/+ 25% of the recommended daily dose (as delineated by the medication's package insert
Who cannot join
- Resistance to conventional antipsychotic drugs
- With antipsychotic agents other than olanzapine, risperidone or haloperidol at start of treatment regimen within 12 hours prior to first dose of study drug
Trial locations and contacts
27 sites in 9 countries.
27 sites in 9 countries
Turkey (Türkiye)8 sites
Pfizer Investigational Site
Ankara
Pfizer Investigational Site
Bursa
Pfizer Investigational Site
Erzurum
Pfizer Investigational Site
Istanbul
Pfizer Investigational Site
Izmir, 35340
Pfizer Investigational Site
Izmir
Pfizer Investigational Site
Manisa
Pfizer Investigational Site
Şişli
South Africa6 sites
Pfizer Investigational Site
Bellair, Durban, KwaZulu-Natal, 4094
Pfizer Investigational Site
Garankuwa, Gauteng, 0208
Pfizer Investigational Site
Krugersdorp, Gauteng, 1739
Pfizer Investigational Site
Noordheuwel, Krugersdorp, Gauteng, 1739
Pfizer Investigational Site
Observatory, Cape Town, Western Cape, 7925
Pfizer Investigational Site
Pinetown, Durban, KwaZulu-Natal, 3600
Egypt4 sites
Pfizer Investigational Site
Alexandria
Pfizer Investigational Site
Asyut
Pfizer Investigational Site
Cairo
Pfizer Investigational Site
Tanta
Greece4 sites
Pfizer Investigational Site
Athens, 11528
Pfizer Investigational Site
Athens, 12462
Pfizer Investigational Site
Athens, 15126
Pfizer Investigational Site
Larissa, Mezourlo, 41110
About this study
Official title: A Multi-Center Study to Examine The Clinical Effects of Cross Titration of Antipsychotics With Ziprasidone in Subjects With Schizophrenia or Schizoaffective Disorder
The primary objective is to compare effectiveness of ziprasidone treatment to current treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric Rating Scale (BPRS) scores versus baseline
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- ziprasidone
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziprasidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score
Secondary outcomes (13)
Change From Baseline In Clinical Global Impression Severity (CGI-S)
Clinical Global Impression Improvement (CGI-I)
Change From Baseline In Positive and Negative Syndrome Scale (PANSS) Total
Change from baseline in scores on the Montgomery-Asberg Depression Rating Scale (MADRS)
Change from baseline in scores on the MADRS Without Items 4, 5
Change from baseline in Global Assessment of Functioning (GAF)
Change From Baseline In Drug Attitude Inventory (DAI)
Change From Baseline In Weight
Change From Baseline In Prolactin And Lipid Levels
Change From Baseline in Modified Simpson Angus Scale (m-SAS) Total Score
Change From Baseline in Barnes Akathisia Scale (BAS)
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Movement Ratings Total Score
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Global Judgment Of Severity Total Score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startNov 2004
- Study completionApr 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 294 participants
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
- NCT00137020
- Sponsor's protocol ID
- A1281117
- Status last verified
- Feb 2021
- First submitted
- 26 Aug 2005
- Last updated
- 21 Feb 2021
- Results posted
- 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 Multi-Center Study to Examine The Clinical Effects of Cross Titration of Antipsychotics With Ziprasidone in Subjects With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00137020
- Acronym / sponsor ID
- A1281117
- Conditions
- Schizophrenia, Psychotic Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Apr 2006
- First posted
- 29 Aug 2005 (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 primary objective is to compare effectiveness of ziprasidone treatment to current treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric Rating Scale (BPRS) scores versus baseline
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary diagnosis of schizophrenia or schizoaffective disorder, using DSM-IV criteria.
- Currently receiving either haloperidol, olanzapine or risperidone within -/+ 25% of the recommended daily dose (as delineated by the medication's package insert
Key exclusion criteria (2 listed)
- Resistance to conventional antipsychotic drugs
- With antipsychotic agents other than olanzapine, risperidone or haloperidol at start of treatment regimen within 12 hours prior to first dose of study drug
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 |
|---|---|---|
| ziprasidone | Drug | – |
Primary outcome
The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score
13 secondary outcomes
Change From Baseline In Clinical Global Impression Severity (CGI-S)
Clinical Global Impression Improvement (CGI-I)
Change From Baseline In Positive and Negative Syndrome Scale (PANSS) Total
Change from baseline in scores on the Montgomery-Asberg Depression Rating Scale (MADRS)
Change from baseline in scores on the MADRS Without Items 4, 5
Change from baseline in Global Assessment of Functioning (GAF)
Change From Baseline In Drug Attitude Inventory (DAI)
Change From Baseline In Weight
Change From Baseline In Prolactin And Lipid Levels
Change From Baseline in Modified Simpson Angus Scale (m-SAS) Total Score
Change From Baseline in Barnes Akathisia Scale (BAS)
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Movement Ratings Total Score
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Global Judgment Of Severity Total Score
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
27 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ziprasidone in people with Schizophrenia and Psychotic Disorders, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 27 sites in 9 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 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 27 sites in Turkey (Türkiye), South Africa, Egypt, Greece, Jordan and 4 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score. 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.