SchizophreniaPhase 2NCT00650611
A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders
A Phase 2 study testing Ziprasidone in people with Schizophrenia and Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 17 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, 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
- 63 participants
- Where
- 17 sitesUnited States
- Study dates
- Dec 2003to Mar 2005
- Phase
- Phase 2
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and teens with Bipolar I Disorder (manic or mixed), schizophrenia or schizoaffective disorder
- Willingness to discontinue all antipsychotic medications during the study period
Who cannot join
- Patients who are clinically stable on treatments that are well tolerated
- Substance-induced psychotic disorders
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Pfizer Investigational Site
Altamonte Springs, Florida, 32701
Pfizer Investigational Site
Belmont, Massachusetts, 02478
Pfizer Investigational Site
Brighton, Massachusetts, 02135
Pfizer Investigational Site
Cincinnati, Ohio, 45224
Pfizer Investigational Site
Cincinnati, Ohio, 45229
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0559
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Kirkland, Washington, 98033
Pfizer Investigational Site
Kirkland, Washington, 98034
Pfizer Investigational Site
Las Vegas, Nevada, 89103
Pfizer Investigational Site
Las Vegas, Nevada, 89117
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Libertyville, Illinois, 60048
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104-3309
Pfizer Investigational Site
San Diego, California, 92111
Pfizer Investigational Site
Turnersville, New Jersey, 08012
About this study
Official title: A 27-Week Open-Label Trial To Characterize The Safety And Tolerability Of Orally Administered Ziprasidone In Children And Adolescent Subjects With Bipolar I Disorder (Manic Or Mixed), Schizophrenia Or Schizoaffective Disorder
The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders
- Conditions
- Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
- Being tested
- Ziprasidone
- Medical subject headings
- Schizophrenia, Bipolar Disorder, 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
Period 1: Initial dose of oral ziprasidone suspension 20 mg twice daily, which was titrated up in 20 mg twice daily increments to a maximum dose of 80 mg twice daily by Day 10.
Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1.
ZiprasidoneDrug
Also called Geodon, Zeldox
Period 1: Initial dose of oral ziprasidone suspension 10 mg twice daily, which was titrated up in 10 mg twice daily increments to a maximum dose of 40 mg twice daily by Day 10.
Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Ziprasidone | Active comparator | Not described Receives: Drug: Ziprasidone |
| High-Dose Ziprasidone | Active comparator | Not described Receives: Drug: Ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events at Baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27.
Measured: 27 weeks
Electrocardiograms and vital signs at Screening, baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27.
Measured: 27 weeks
Laboratory data at Screening and Weeks 3, 12, and 27.
Measured: 27 weeks
Secondary outcomes (7)
Clinical Global Impressions-Improvement (CGI-I) scale scores on Day 4 and at Weeks 1, 2, and 3.
Measured: 3 weeks
Mean change from baseline in Childrens' Global Assessment Scale (CGAS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.
Measured: 27 weeks
Serum concentrations of ziprasidone and its major metabolites at Weeks 1, 3, 12, and 27.
Measured: 27 weeks
Mean change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.
Measured: 27 weeks
Mean change from baseline in Young Mania Rating Scale (YMRS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.
Measured: 27 weeks
Mean change from baseline in Brief Psychiatric Rating Scale-Anchored (BPRS-A) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.
Measured: 27 weeks
Mean change from baseline in movement disorder rating scale scores at Weeks 3, 12, and 27.
Measured: 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startDec 2003
- Study completionMar 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 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
- NCT00650611
- Sponsor's protocol ID
- A1281123
- 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 27-Week Open-Label Trial To Characterize The Safety And Tolerability Of Orally Administered Ziprasidone In Children And Adolescent Subjects With Bipolar I Disorder (Manic Or Mixed), Schizophrenia Or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00650611
- Acronym / sponsor ID
- A1281123
- Conditions
- Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 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
- Mar 2005 (actual)
- First posted
- 2 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 evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Ziprasidone | Active comparator | Drug: Ziprasidone |
| High-Dose Ziprasidone | Active comparator | Drug: Ziprasidone |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children and teens with Bipolar I Disorder (manic or mixed), schizophrenia or schizoaffective disorder
- Willingness to discontinue all antipsychotic medications during the study period
Key exclusion criteria (2 listed)
- Patients who are clinically stable on treatments that are well tolerated
- Substance-induced psychotic disorders
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, ZeldoxPeriod 1: Initial dose of oral ziprasidone suspension 20 mg twice daily, which was titrated up in 20 mg twice daily increments to a maximum dose of 80 mg twice daily by Day 10. Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1. | Drug | High-Dose Ziprasidone |
| ZiprasidoneAlso: Geodon, ZeldoxPeriod 1: Initial dose of oral ziprasidone suspension 10 mg twice daily, which was titrated up in 10 mg twice daily increments to a maximum dose of 40 mg twice daily by Day 10. Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1. | Drug | Low-Dose Ziprasidone |
Primary outcome
Adverse events at Baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27.
Time frame: 27 weeks
Electrocardiograms and vital signs at Screening, baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27.
Time frame: 27 weeks
Laboratory data at Screening and Weeks 3, 12, and 27.
Time frame: 27 weeks
7 secondary outcomes
Clinical Global Impressions-Improvement (CGI-I) scale scores on Day 4 and at Weeks 1, 2, and 3.
Time frame: 3 weeks
Mean change from baseline in Childrens' Global Assessment Scale (CGAS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.
Time frame: 27 weeks
Serum concentrations of ziprasidone and its major metabolites at Weeks 1, 3, 12, and 27.
Time frame: 27 weeks
Mean change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.
Time frame: 27 weeks
Mean change from baseline in Young Mania Rating Scale (YMRS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.
Time frame: 27 weeks
Mean change from baseline in Brief Psychiatric Rating Scale-Anchored (BPRS-A) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.
Time frame: 27 weeks
Mean change from baseline in movement disorder rating scale scores at Weeks 3, 12, and 27.
Time frame: 27 weeks
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
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ziprasidone in people with Schizophrenia and Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 17 sites in United States.
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 17 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Adverse events at Baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27. (time frame: 27 weeks). The study lists 3 primary outcomes in all. 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.