Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Ziprasidone; Placebo
Intervention description: 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.; 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 MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
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.
Enrollment: 23.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        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 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.