SchizophreniaPhase 3NCT00159770
Effect And Safety Of Ziprasidone Compared To Other Atypical Antipsychotic Drug In Schizophrenic Patients
A Phase 3 study testing ziprasidone versus olanzapine , risperidone or quetiapine, Panss , CGI-C, UKU-SERS-Pa and Blood tests in people with Schizophrenia and Schizoaffective Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 43 sites in 4 countries.
Trial summary
Evaluation of the antipsychotic efficacy and safety of ziprasidone versus olanzapine, risperidone or quetiapine in patients with schizophrenia, schizoaffective and schizophreniform disorders under naturalistic conditions of clinical practice Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Psychotic Disorders
- What is being tested?
- ziprasidone versus olanzapine , risperidone or quetiapine, Panss , CGI-C, UKU-SERS-Pa and Blood tests
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 290 participants
- Where
- 43 sitesin 4 countries
- Study dates
- Nov 2001to 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
- Inpatients or outpatients with schizophrenia, schizoaffective and schizophreniform disorders (DSM-IV).
- Patients without adequate current treatment (i.e. intolerance to their current treatment or lack of efficacy of current treatment) based on clinical judgement of the investigator
Who cannot join
- A history of intolerance to ziprasidone, olanzapine, risperidone or quetiapine or any of its ingredients
Trial locations and contacts
43 sites in 4 countries.
43 sites in 4 countries
Denmark22 sites
Pfizer Investigational Site
Aalborg, 9100
Pfizer Investigational Site
Arhus C, 8000
Pfizer Investigational Site
Augustenborg, 6440
Pfizer Investigational Site
Ballerup Municipality, 2750
Pfizer Investigational Site
Brovst, 9460
Pfizer Investigational Site
Copenhagen, 2100
Pfizer Investigational Site
Dianalund, 4293
Pfizer Investigational Site
Esbjerg, 6700
Pfizer Investigational Site
Esbjerg N, 6715
Pfizer Investigational Site
Glostrup Municipality, 2600
Pfizer Investigational Site
Haderslev, 6100
Pfizer Investigational Site
Holbæk, 4300
Pfizer Investigational Site
Kjellerup, 8620
Pfizer Investigational Site
København S, 2300
Pfizer Investigational Site
Kolding, 6000
Pfizer Investigational Site
Lemvig, 7620
Pfizer Investigational Site
Odense C, 5000
Pfizer Investigational Site
Ringkøbing, 6950
Pfizer Investigational Site
Risskov, 8240
Pfizer Investigational Site
Vejle, 7100
Pfizer Investigational Site
Viborg, 8800
Pfizer Investigational Site
Vordingborg, 4760
Switzerland13 sites
Pfizer Investigational Site
Basel, Canton of Basel-City, CH-4025
Pfizer Investigational Site
Bern, Canton of Bern, CH-3000
Pfizer Investigational Site
Bulle, CH - 1630
Pfizer Investigational Site
Chêne-Bourg, 1225
Pfizer Investigational Site
Delémont, CH-2800
Pfizer Investigational Site
Lausanne, Canton of Vaud, 1003
Pfizer Investigational Site
Oetwil, CH-8618
Pfizer Investigational Site
Prangins, Canton of Vaud, 1197
Pfizer Investigational Site
Riehen, 4125
Pfizer Investigational Site
Saint Urban, 4915
Pfizer Investigational Site
Sankt Gallen, Canton of St. Gallen, 9000
Pfizer Investigational Site
Solothurn, CH-4503
Pfizer Investigational Site
Zurich, Canton of Zurich, 8029
Finland7 sites
Pfizer Investigational Site
Forssa, 30101
Pfizer Investigational Site
Helsinki, 00099
Pfizer Investigational Site
Jarvenpaa, 04400
Pfizer Investigational Site
Kiviranta, 95410
Pfizer Investigational Site
Mikkeli, 50520
Pfizer Investigational Site
Turku, 20700
Pfizer Investigational Site
Tuusula, 04301
About this study
Official title: Tolerability, Safety, And Efficacy Of Ziprasidone (80 - 160 Mg/D) Versus Olanzapine (10 - 20 Mg/D), Risperidone (4 - 8 Mg/D) Or Quetiapine (300 - 750 Mg/D) In Pretreated Patients With Schizophrenia, Schizoaffective Disorder Or Schizophreniform Disorders - A 12-Week Open-Label, Multicenter Clinical Trial.
Evaluation of the antipsychotic efficacy and safety of ziprasidone versus olanzapine, risperidone or quetiapine in patients with schizophrenia, schizoaffective and schizophreniform disorders under naturalistic conditions of clinical practice
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychotic Disorders
- Being tested
- ziprasidone versus olanzapine , risperidone or quetiapine, Panss , CGI-C, UKU-SERS-Pa, Blood tests
- 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.
ziprasidone versus olanzapine , risperidone or quetiapineDrug
Panss , CGI-C, UKU-SERS-PaBehavioural
Blood testsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS (The Positive And Negative Syndrome Scale) in a 12 week period
Secondary outcomes (1)
CGI-C score (Clinical Global Impression of Change), UKU-SERS-Pa (Patient self rating version). Safety and tolerability: ECG, serum cholesterol, triglycerides, prolactin, glucose and body weight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startNov 2001
- 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
- None (open label)
- Enrolment
- 290 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
- NCT00159770
- Sponsor's protocol ID
- A1281079
- Status last verified
- Feb 2021
- First submitted
- 8 Sep 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
- Tolerability, Safety, And Efficacy Of Ziprasidone (80 - 160 Mg/D) Versus Olanzapine (10 - 20 Mg/D), Risperidone (4 - 8 Mg/D) Or Quetiapine (300 - 750 Mg/D) In Pretreated Patients With Schizophrenia, Schizoaffective Disorder Or Schizophreniform Disorders - A 12-Week Open-Label, Multicenter Clinical Trial.
- ClinicalTrials.gov ID
- NCT00159770
- Acronym / sponsor ID
- A1281079
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychotic Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2001
- Study completion
- Sep 2004
- First posted
- 12 Sep 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.
Evaluation of the antipsychotic efficacy and safety of ziprasidone versus olanzapine, risperidone or quetiapine in patients with schizophrenia, schizoaffective and schizophreniform disorders under naturalistic conditions of clinical practice
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inpatients or outpatients with schizophrenia, schizoaffective and schizophreniform disorders (DSM-IV).
- Patients without adequate current treatment (i.e. intolerance to their current treatment or lack of efficacy of current treatment) based on clinical judgement of the investigator
Key exclusion criteria (1 listed)
- A history of intolerance to ziprasidone, olanzapine, risperidone or quetiapine or any of its ingredients
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 versus olanzapine , risperidone or quetiapine | Drug | – |
| Panss , CGI-C, UKU-SERS-Pa | Behavioural | – |
| Blood tests | Procedure or surgery | – |
Primary outcome
PANSS (The Positive And Negative Syndrome Scale) in a 12 week period
1 secondary outcome
CGI-C score (Clinical Global Impression of Change), UKU-SERS-Pa (Patient self rating version). Safety and tolerability: ECG, serum cholesterol, triglycerides, prolactin, glucose and body weight
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.
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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
43 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ziprasidone versus olanzapine , risperidone or quetiapine, Panss , CGI-C, UKU-SERS-Pa and Blood tests in people with Schizophrenia and Schizoaffective Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 43 sites in 4 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 1 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 43 sites in Denmark, Switzerland, Finland, Iceland. 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?
PANSS (The Positive And Negative Syndrome Scale) in a 12 week period. 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.