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Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

Primary Purpose

Bipolar Disorder

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ziprasidone oral capsules
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Children and Adolescents with Bipolar I Disorder (manic or mixed)

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Open

    Arm Description

    Outcomes

    Primary Outcome Measures

    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)
    Change from baseline in Physical exam
    Change from baseline in Clinical laboratory tests
    Change from baseline in body weight, height, BMI, BMI z score, and waist circumference
    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)

    Secondary Outcome Measures

    Change from Baseline in Young Mania Rating Scale (YMRS)
    Change from Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ)
    Change from Baseline in Child Health Questionnaire
    Change from Baseline in School Placement Questionnaire
    Change from Baseline in CNS Vital Signs Cognitive Test Battery
    Change from Baseline in CNS Vital Signs Cognitive Test Sedation Item
    Change from Baseline in Simpson-Angus Rating Scale (SARS)
    Change from Baseline in Barnes Akathisia Rating Scale (BAS)
    Change from Baseline in Abnormal Involuntary Movement Scale (AIMS)
    Change from Baseline in Childrens Global Assessment Scales
    Change from Baseline in Tanner Adolescent Pubertal Self-Assessment

    Full Information

    First Posted
    May 14, 2010
    Last Updated
    February 18, 2021
    Sponsor
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01124877
    Brief Title
    Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    October 2011 (Anticipated)
    Study Completion Date
    October 2011 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Disorder
    Keywords
    Children and Adolescents with Bipolar I Disorder (manic or mixed)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Open
    Arm Type
    Other
    Intervention Type
    Drug
    Intervention Name(s)
    ziprasidone oral capsules
    Other Intervention Name(s)
    Zeldox, Geodon
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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
    Title
    Change from baseline in Physical exam
    Time Frame
    week 26
    Title
    Change from baseline in Clinical laboratory tests
    Time Frame
    weeks 2, 6, 18,26
    Title
    Change from baseline in body weight, height, BMI, BMI z score, and waist circumference
    Time Frame
    weeks 6, 26
    Title
    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
    Secondary Outcome Measure Information:
    Title
    Change from Baseline in Young Mania Rating Scale (YMRS)
    Time Frame
    weeks 2, 6, 18, and 26
    Title
    Change from Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ)
    Time Frame
    weeks 2, 6, 18, and 26
    Title
    Change from Baseline in Child Health Questionnaire
    Time Frame
    weeks 6 and 26
    Title
    Change from Baseline in School Placement Questionnaire
    Time Frame
    weeks 6 and 26
    Title
    Change from Baseline in CNS Vital Signs Cognitive Test Battery
    Time Frame
    weeks 6 and 26
    Title
    Change from Baseline in CNS Vital Signs Cognitive Test Sedation Item
    Time Frame
    weeks 6 and 26
    Title
    Change from Baseline in Simpson-Angus Rating Scale (SARS)
    Time Frame
    weeks 1, 2, 6, 10, 14, 18, 22 and 26
    Title
    Change from Baseline in Barnes Akathisia Rating Scale (BAS)
    Time Frame
    weeks 1, 2, 6, 10, 14, 18, 22 and 26
    Title
    Change from Baseline in Abnormal Involuntary Movement Scale (AIMS)
    Time Frame
    weeks 1, 2, 6, 10, 14, 18, 22 and 26
    Title
    Change from Baseline in Childrens Global Assessment Scales
    Time Frame
    weeks 2, 6, 18, and 26
    Title
    Change from Baseline in Tanner Adolescent Pubertal Self-Assessment
    Time Frame
    26 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281197&StudyName=Safety%20And%20Tolerability%20Of%20Flexible%20Doses%20Of%20Oral%20Ziprasidone%20In%20Children%20And%20Adolescents%20With%20Bipolar%20I%20Disorder%20%28Manic%20Or%20Mixed%29
    Description
    To obtain contact information for a study center near you, click here.

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    Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

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