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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 August 14, 2019

Study Location
Hugo W. Moser Research Institute at Kennedy Krieger Institute (Administrative)
Baltimore, Maryland, 21205 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder
Females and Males
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.
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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 and
completed at least 3 weeks of double blind treatment before entering this open label

- 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.
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- 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withdrawn from the study.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

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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