Bipolar DisorderPhase 3NCT01124877
Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
A Phase 3 study testing ziprasidone oral capsules in people with Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
The purpose of this study is to assess the safety and tolerability of ziprasidone during a long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder (Manic or Mixed). Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- ziprasidone oral capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Oct 2011
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The subjects must have received study medication in Study A1281196.
- In the investigator's opinion, the subject must be likely to continue to benefit from antipsychotic therapy and must have been free from any clinically significant safety concerns during the preceding double blind study.
Who cannot join
- Subjects who require treatment with drugs that are known to consistently prolong the QT interval.
- Subjects who are judged by the investigator as being at imminent risk of suicide.
About this study
Official title: 26 Week Open Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
The purpose of this study is to assess the safety and tolerability of ziprasidone during a long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder (Manic or Mixed).
- Conditions
- Bipolar Disorder
- Being tested
- ziprasidone oral capsules
- Keywords
- Children and Adolescents with Bipolar I Disorder (manic or mixed)
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziprasidone oral capsulesDrug
Also called Zeldox, Geodon
Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength will be provided. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.
| Study group | Role | What they receive |
|---|---|---|
| Open | Other | Not described Receives: Drug: ziprasidone oral capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in blood pressure and pulse Change from baseline in electrocardiogram (QTc) Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S)
Measured: weeks 1, 2, 6, 10, 14, 18, 22, and 26
Change from baseline in Physical exam
Measured: week 26
Change from baseline in Clinical laboratory tests
Measured: weeks 2, 6, 18,26
Change from baseline in body weight, height, BMI, BMI z score, and waist circumference
Measured: weeks 6, 26
Adverse events -Only number of subjects with adverse events or serious adverse events Columbia Suicide Severity Rating Scale Change from Baseline in Child Depression Rating Scale - Revised (CDRS-R)
Measured: weeks 1, 2, 6, 10, 14, 18, 22, and 26
Secondary outcomes (11)
Change from Baseline in Young Mania Rating Scale (YMRS)
Measured: weeks 2, 6, 18, and 26
Change from Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ)
Measured: weeks 2, 6, 18, and 26
Change from Baseline in Child Health Questionnaire
Measured: weeks 6 and 26
Change from Baseline in School Placement Questionnaire
Measured: weeks 6 and 26
Change from Baseline in CNS Vital Signs Cognitive Test Battery
Measured: weeks 6 and 26
Change from Baseline in CNS Vital Signs Cognitive Test Sedation Item
Measured: weeks 6 and 26
Change from Baseline in Simpson-Angus Rating Scale (SARS)
Measured: weeks 1, 2, 6, 10, 14, 18, 22 and 26
Change from Baseline in Barnes Akathisia Rating Scale (BAS)
Measured: weeks 1, 2, 6, 10, 14, 18, 22 and 26
Change from Baseline in Abnormal Involuntary Movement Scale (AIMS)
Measured: weeks 1, 2, 6, 10, 14, 18, 22 and 26
Change from Baseline in Childrens Global Assessment Scales
Measured: weeks 2, 6, 18, and 26
Change from Baseline in Tanner Adolescent Pubertal Self-Assessment
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT01124877
- Sponsor's protocol ID
- A1281197
- Status last verified
- Feb 2021
- First submitted
- 14 May 2010
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
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
- 26 Week Open Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
- ClinicalTrials.gov ID
- NCT01124877
- Acronym / sponsor ID
- A1281197
- Conditions
- Bipolar Disorder
- Keywords
- Children and Adolescents with Bipolar I Disorder (manic or mixed)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 17 May 2010 (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 assess the safety and tolerability of ziprasidone during a long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder (Manic or Mixed).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open | Other | Drug: ziprasidone oral capsules |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The subjects must have received study medication in Study A1281196.
- In the investigator's opinion, the subject must be likely to continue to benefit from antipsychotic therapy and must have been free from any clinically significant safety concerns during the preceding double blind study.
Key exclusion criteria (2 listed)
- Subjects who require treatment with drugs that are known to consistently prolong the QT interval.
- Subjects who are judged by the investigator as being at imminent risk of suicide.
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 oral capsulesAlso: Zeldox, GeodonOral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength will be provided. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID. | Drug | Open |
Primary outcome
Change from Baseline in blood pressure and pulse Change from baseline in electrocardiogram (QTc) Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S)
Time frame: weeks 1, 2, 6, 10, 14, 18, 22, and 26
Change from baseline in Physical exam
Time frame: week 26
Change from baseline in Clinical laboratory tests
Time frame: weeks 2, 6, 18,26
Change from baseline in body weight, height, BMI, BMI z score, and waist circumference
Time frame: weeks 6, 26
Adverse events -Only number of subjects with adverse events or serious adverse events Columbia Suicide Severity Rating Scale Change from Baseline in Child Depression Rating Scale - Revised (CDRS-R)
Time frame: weeks 1, 2, 6, 10, 14, 18, 22, and 26
11 secondary outcomes
Change from Baseline in Young Mania Rating Scale (YMRS)
Time frame: weeks 2, 6, 18, and 26
Change from Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ)
Time frame: weeks 2, 6, 18, and 26
Change from Baseline in Child Health Questionnaire
Time frame: weeks 6 and 26
Change from Baseline in School Placement Questionnaire
Time frame: weeks 6 and 26
Change from Baseline in CNS Vital Signs Cognitive Test Battery
Time frame: weeks 6 and 26
Change from Baseline in CNS Vital Signs Cognitive Test Sedation Item
Time frame: weeks 6 and 26
Change from Baseline in Simpson-Angus Rating Scale (SARS)
Time frame: weeks 1, 2, 6, 10, 14, 18, 22 and 26
Change from Baseline in Barnes Akathisia Rating Scale (BAS)
Time frame: weeks 1, 2, 6, 10, 14, 18, 22 and 26
Change from Baseline in Abnormal Involuntary Movement Scale (AIMS)
Time frame: weeks 1, 2, 6, 10, 14, 18, 22 and 26
Change from Baseline in Childrens Global Assessment Scales
Time frame: weeks 2, 6, 18, and 26
Change from Baseline in Tanner Adolescent Pubertal Self-Assessment
Time frame: 26 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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 Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ziprasidone oral capsules in people with Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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 blood pressure and pulse Change from baseline in electrocardiogram (QTc) Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) (time frame: weeks 1, 2, 6, 10, 14, 18, 22, and 26). The study lists 5 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.