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Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder

Last updated on December 8, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 and
completed at least 3 weeks of double blind treatment 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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withdrawn from the study.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.

NCT03768726
Pfizer
Not yet recruiting
Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder

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Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder
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)
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).

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.

Interventional
Phase 3
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

Bipolar Disorder
Drug: 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.

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.

Intervention: Drug: Ziprasidone
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
55
Same as current
September 7, 2020
September 7, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria

  • 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 and completed at least 3 weeks of double blind treatment 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

Exclusion Criteria

  • 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.
Sexes Eligible for Study: All
10 Years to 17 Years   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03768726
A1281201
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now