SchizophreniaPhase 4NCT00650429
A Study of the Efficacy and Safety of Ziprasidone for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
A Phase 4 study testing Ziprasidone in people with Schizophrenia and Schizoaffective Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 4 sites in Mexico.
Trial summary
This study was conducted to examine the efficacy and tolerability of ziprasidone intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin American population. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- 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
- 28 participants
- Where
- 4 sitesMexico
- Study dates
- Oct 2003to May 2005
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder.
- Inpatients with acute exacerbation of psychotic symptoms.
- Patients with a minimum score of 40 on the BPRS scale (1-7).
Who cannot join
- Concurrent treatment with antipsychotic agents at study drug initiation (within 12 hours prior to study drug initiation); for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and study drug initiation.
- Treatment with antidepressants or mood stabilizers within 7 days of start of ziprasidone.
- Patients currently receiving clozapine.
- Patients at immediate risk of committing harm to self or others.
Trial locations and contacts
4 sites in 1 country.
Mexico4 sites
Pfizer Investigational Site
DF, 14420
Pfizer Investigational Site
Mexico City, 14050
Pfizer Investigational Site
Mexico D F, 14269
Pfizer Investigational Site
Monterrey, Nuevo León, 64800
About this study
Official title: Ziprasidone Intramuscular/Oral In The Treatment Of Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder: A Six-Week Open Administration Study
This study was conducted to examine the efficacy and tolerability of ziprasidone intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin American population.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- 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
Also called Geodon, Zeldox
IM ziprasidone at an initial dose of 10 or 20 mg for the first 3 days; additional doses could be administered according to clinical need, with the maximum total daily IM dose of 40 mg. On Day 4, IM treatment was switched to oral (PO) treatment at an initial dose of 40 mg twice daily for the first 2 days; doses could be subsequently adjusted within the range of 40 to 80 mg twice daily. Total treatment duration was 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | 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 Brief Psychiatric Rating Scale (BPRS) total score
Measured: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Secondary outcomes (12)
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale score
Measured: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scale score
Measured: Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Simpson-Angus Scale (SAS)
Measured: Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)
Barnes Akathisia Scale (BAS)
Measured: Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)
Laboratory tests
Measured: Screening and Week 6
Electrocardiogram
Measured: Screening and Week 6
Adverse events
Measured: Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Abnormal Involuntary Movement Scale (AIMS)
Measured: Day 1 (IM), Day 4 (Switch), and Week 6 (PO)
Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score
Measured: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Change from baseline to endpoint in Covi Anxiety Scale score
Measured: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Change from baseline to endpoint in Positive PANSS subscale score
Measured: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Change from baseline to endpoint in Negative PANSS subscale score
Measured: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
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 startOct 2003
- Study completionMay 2005
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
- 28 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
- NCT00650429
- Sponsor's protocol ID
- A1281056
- 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
- Ziprasidone Intramuscular/Oral In The Treatment Of Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder: A Six-Week Open Administration Study
- ClinicalTrials.gov ID
- NCT00650429
- Acronym / sponsor ID
- A1281056
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- May 2005 (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.
This study was conducted to examine the efficacy and tolerability of ziprasidone intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin American population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Ziprasidone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of schizophrenia or schizoaffective disorder.
- Inpatients with acute exacerbation of psychotic symptoms.
- Patients with a minimum score of 40 on the BPRS scale (1-7).
Key exclusion criteria (4 listed)
- Concurrent treatment with antipsychotic agents at study drug initiation (within 12 hours prior to study drug initiation); for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and study drug initiation.
- Treatment with antidepressants or mood stabilizers within 7 days of start of ziprasidone.
- Patients currently receiving clozapine.
- Patients at immediate risk of committing harm to self or others.
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, ZeldoxIM ziprasidone at an initial dose of 10 or 20 mg for the first 3 days; additional doses could be administered according to clinical need, with the maximum total daily IM dose of 40 mg. On Day 4, IM treatment was switched to oral (PO) treatment at an initial dose of 40 mg twice daily for the first 2 days; doses could be subsequently adjusted within the range of 40 to 80 mg twice daily. Total treatment duration was 6 weeks. | Drug | Arm A |
Primary outcome
Change from baseline to endpoint in Brief Psychiatric Rating Scale (BPRS) total score
Time frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
12 secondary outcomes
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale score
Time frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scale score
Time frame: Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Simpson-Angus Scale (SAS)
Time frame: Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)
Barnes Akathisia Scale (BAS)
Time frame: Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)
Laboratory tests
Time frame: Screening and Week 6
Electrocardiogram
Time frame: Screening and Week 6
Adverse events
Time frame: Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Abnormal Involuntary Movement Scale (AIMS)
Time frame: Day 1 (IM), Day 4 (Switch), and Week 6 (PO)
Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Change from baseline to endpoint in Covi Anxiety Scale score
Time frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Change from baseline to endpoint in Positive PANSS subscale score
Time frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Change from baseline to endpoint in Negative PANSS subscale score
Time frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
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
4 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 Schizophrenia and Schizoaffective Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 4 sites in Mexico.
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 4 sites in Mexico. 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 to endpoint in Brief Psychiatric Rating Scale (BPRS) total score (time frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)). 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.