Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder
NCT03768726
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- Evidence of personally signed and dated informed consent document by the legal representative and an assent document by the subject .
- Subjects and their legal guardians who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- The subjects must have received investigational product in Study A1281198 before entering this open label extension.
- In the investigator's opinion, the subject must be likely to benefit from antipsychotic therapy .
- All fertile male subjects and female subjects of childbearing potential who are sexually active and/or their legal guardians, as appropriate, must agree that a highly effective method of contraception
- Any subjects from the preceding double blind trail who experienced a serious adverse
event which required study medication to be discontinued and the subject to be
withdrawn from the study. Subjects who experienced cardiac arrhythmias, conduction
abnormalities, or QTc prolongation (confirmed and persistent Fridericia's correction
(QTcF) >480 msec or increase from baseline QTcF >60 msec) during the preceding study.
- Subjects requiring any medications not allowed by the Concomitant Medication Table 12
(see "Concomitant Treatment(s)").
- Subjects who require treatment with drugs that are known to consistently prolong the
QT interval (see Concomitant Medication Table 12).
- Subjects who are judged by the investigator as being at imminent risk of suicide.
- Subjects living in the same home as another study participant or having the same
caregiver during the same enrollment period (Such subjects can be enrolled in the
study at different times but may not be in the study at the same time).
- Subjects should be excluded or a risk assessment should be done to verify that it is
safe for the subject to participate in the trial if the subject's responses on the C
SSRS or other information based on the investigator's judgment indicate:
- Suicide ideation associated with actual intent and a method or plan such that a
positive response ('Yes') is made on items 4 or 5 of the suicidal ideation
subscale of the C SSRS; or
- Any suicide behaviors such that a determination of 'yes' is made to any of the
suicide behavior items of the C SSRS.
- Pregnant female subjects, breastfeeding female subjects.
- Participation in other studies other than the preceding Study.
- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.
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Descriptive Information | |||||||
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Brief Title ICMJE | Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder | ||||||
Official Title ICMJE | 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 (MOST RECENT EPISODE MANIC) | ||||||
Brief Summary | This 26-week open-label extension study is designed to provide information on the safety and tolerability of oral ziprasidone (20-80 mg BID (twice daily) with meals) during long-term administration in children and adolescents with Bipolar I Disorder (current or most recent episode manic). | ||||||
Detailed Description | Study A1281201 is a 6 month, open label extension study of the ongoing double blind, randomized, placebo controlled study of ziprasidone in pediatric Bipolar Disorder (Study A1281198). Study A1281201 will enroll adolescents aged 10 to 17 years with Bipolar I Disorder who have participated in double blind Study A1281198. In order to be enrolled in this open label extension trial, subjects must have met the enrollment criteria for Study A1281198, and must meet the inclusion and exclusion criteria for Study A1281201 at the extension study Baseline visit (last visit in the double blind study). The purpose of adding this extension study to the ongoing Geodon pediatric bipolar program is to obtain additional longer term safety data in children and adolescents with Bipolar I disorder treated with ziprasidone. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Subjects would completed A1281198 will be transitioned under double blind conditions to 26 weeks of treatment with flexibly dosed opened label ziprasidone. Masking: None (Open Label)Masking Description: Subjects who participate in A1281198 will be transitioned under double blind conditions (during the first two weeks of the study) to 26 weeks of treatment with flexibly dosed opened label ziprasidone. Primary Purpose: Treatment
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Condition ICMJE | Bipolar Disorder | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Ziprasidone
All investigational products will be provided by Pfizer and will include oral ziprasidone capsules of 20, 40, 60, and 80 mg strength. Matching placebo capsules will also be supplied for the initial 1-14 day dose transition period. During the transition period all subjects will receive both active ziprasidone and placebo capsules. The placebo capsules are used to maintain the blind to the treatment assignment of the subjects in A1281198 . All medication will be packaged in childproof blister cards with columns for AM and for PM capsules. During the dose transition period (Weeks 1-2, Days 1-14), subjects will receive a study drug blister card for each week of transition dosing. Subjects weighing greater than 45 kg will receive 2 weeks of transition medication, while subjects weighing less than 45 kg will receive 1 week of transition medication. Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE | 23 | ||||||
Original Estimated Enrollment ICMJE | 55 | ||||||
Actual Study Completion Date ICMJE | July 31, 2020 | ||||||
Actual Primary Completion Date | July 31, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 10 Years to 17 Years (Child) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | Colombia, Philippines, Ukraine | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03768726 | ||||||
Other Study ID Numbers ICMJE | A1281201 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |