Schizoaffective DisorderPhase 4NCT00649064
A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs
A Phase 4 study testing Ziprasidone in people with Schizoaffective Disorder and Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 3 sites in Taiwan.
Trial summary
The purpose of this study is to see if differences exist in outcome in patients with schizophrenia or schizoaffective disorder who were switched from other antipsychotics to ziprasidone. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizoaffective Disorder, Schizophrenia
- What is being tested?
- Ziprasidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesTaiwan
- Study dates
- Dec 2003to Sep 2004
- 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
- Diagnosis of schizophrenia or schizoaffective disorder
- Outpatients for at least 3 months on treatment with sulpiride, olanzapine, quetiapine, or risperidone and at least a partial beneficial response to typical antipsychotic treatment including for the current episode
- Partial improvement in symptoms that justified a switch to ziprasidone
Who cannot join
- Diagnosis of major depression or occurrence of moderate depressive symptoms
- Resistance to conventional antipsychotic drugs
- Treatment with other drugs such as antiseizure medications, antipsychotics, antidepressants, or mood stabilizing agents that might interfere with the assessement of the efficacy of ziprasidone
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Pfizer Investigational Site
Changhua
Pfizer Investigational Site
Tainan
Pfizer Investigational Site
Taipei
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 purpose of this study is to see if differences exist in outcome in patients with schizophrenia or schizoaffective disorder who were switched from other antipsychotics to ziprasidone.
- Conditions
- Schizoaffective Disorder, Schizophrenia
- Being tested
- Ziprasidone
- Medical subject headings
- Psychotic Disorders, 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
Ziprasidone 40 mg capsules twice daily for the first 7 days followed by flexible dosing between 40 and 80 mg twice daily for the remaining 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ziprasidone | 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 Brief Psychiatric Rating Scale (BPRS) total score
Measured: Week 6
Secondary outcomes (10)
Adverse events
Measured: Weeks 1, 2, and 6
Change from baseline in weight
Measured: Baseline and Week 6
Change from baseline in prolactin and lipid levels
Measured: Baseline and Week 6
Change from baseline in electrocardiogram
Measured: Baseline and Week 6
Change from baseline in Positive and Negative Symptom Scale (PANSS), including PANSS total scores and PANSS positive, PANSS negative, and PANSS general subscale scores
Measured: Baseline and Weeks 1, 2, and 6
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores
Measured: Baseline and Weeks 1, 2, and 6
Clinical Global Impressions-Improvement (CGI-I) scale scores
Measured: Baseline (using historical data) and Weeks 1, 2, and 6
Change from baseline in movement disorder rating scales, including Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movement Scale (AIMS)
Measured: Baseline and Week 6
Change from baseline in vital signs
Measured: Baseline and Weeks 1, 2, and 6
Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores
Measured: Baseline and Week 6
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 startDec 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 Schizoaffective DisorderStudies 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
- 46 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
- NCT00649064
- Sponsor's protocol ID
- A1281120
- Status last verified
- Feb 2021
- First submitted
- 28 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 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
- NCT00649064
- Acronym / sponsor ID
- A1281120
- Conditions
- Schizoaffective Disorder, Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 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 see if differences exist in outcome in patients with schizophrenia or schizoaffective disorder who were switched from other antipsychotics to ziprasidone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ziprasidone | 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 (3 listed)
- Diagnosis of schizophrenia or schizoaffective disorder
- Outpatients for at least 3 months on treatment with sulpiride, olanzapine, quetiapine, or risperidone and at least a partial beneficial response to typical antipsychotic treatment including for the current episode
- Partial improvement in symptoms that justified a switch to ziprasidone
Key exclusion criteria (3 listed)
- Diagnosis of major depression or occurrence of moderate depressive symptoms
- Resistance to conventional antipsychotic drugs
- Treatment with other drugs such as antiseizure medications, antipsychotics, antidepressants, or mood stabilizing agents that might interfere with the assessement of the efficacy of ziprasidone
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, ZeldoxZiprasidone 40 mg capsules twice daily for the first 7 days followed by flexible dosing between 40 and 80 mg twice daily for the remaining 5 weeks. | Drug | Ziprasidone |
Primary outcome
Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score
Time frame: Week 6
10 secondary outcomes
Adverse events
Time frame: Weeks 1, 2, and 6
Change from baseline in weight
Time frame: Baseline and Week 6
Change from baseline in prolactin and lipid levels
Time frame: Baseline and Week 6
Change from baseline in electrocardiogram
Time frame: Baseline and Week 6
Change from baseline in Positive and Negative Symptom Scale (PANSS), including PANSS total scores and PANSS positive, PANSS negative, and PANSS general subscale scores
Time frame: Baseline and Weeks 1, 2, and 6
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores
Time frame: Baseline and Weeks 1, 2, and 6
Clinical Global Impressions-Improvement (CGI-I) scale scores
Time frame: Baseline (using historical data) and Weeks 1, 2, and 6
Change from baseline in movement disorder rating scales, including Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movement Scale (AIMS)
Time frame: Baseline and Week 6
Change from baseline in vital signs
Time frame: Baseline and Weeks 1, 2, and 6
Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores
Time frame: Baseline and Week 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.
Related trials for Schizoaffective Disorder
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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 4 study testing Ziprasidone in people with Schizoaffective Disorder and Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 3 sites in Taiwan.
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 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: 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 3 sites in Taiwan. 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?
Change from baseline in Brief Psychiatric Rating Scale (BPRS) 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.