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Completed

NCT Number: NCT00265330

Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)

The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed)

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participation in double-blind treatment study A1281132, meeting specific criteria of duration and safety

Exclusion criteria

  • Imminent risk of suicide or homicide, as judged by the site investigator;serious adverse event related to study medication in study A1281132; significant prolongation of QT interval in study A1281132.

Treatment and study plan

Ziprasidone oral capsules

Drug

Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .

Primary outcomes

  1. Young Mania Rating Scale (YMRS) Total Score Change From Baseline

    Time frame: baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)

    YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132.

  2. Clinical Global Impression of Severity (CGI-S) Change From Baseline

    Time frame: baseline and 26 Weeks; 26 Weeks LOCF

    CGI-S Scale:standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132).

  3. Incidence of Lab Abnormalities

    Time frame: Week 26

    number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality.

  4. Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol

    Time frame: Week 6, Week 26

    Mean Change: lab value at observation minus lab value at baseline.

  5. Change in Hormones

    Time frame: Week 6, Week 26

    Mean Change: lab value at observation minus lab value at baseline

  6. Mean Change From Baseline in Supine Systolic Blood Pressure

    Time frame: Week 1 through Week 26

    Mean Change: vital sign value at observation minus vital sign value at baseline

  7. Mean Change From Baseline in Supine Diastolic Blood Pressure

    Time frame: Week 1 through Week 26

    Mean Change: vital sign value at observation minus vital sign value at baseline

  8. Mean Change From Baseline in Supine Pulse Rates

    Time frame: Week 1 through Week 26

    Mean Change: vital sign value at observation minus vital sign value at baseline

  9. Mean Change From Baseline in Standing Systolic Blood Pressure

    Time frame: Week 1 through Week 26

    Mean Change: vital sign value at observation minus vital sign value at baseline

  10. Mean Change From Baseline in Standing Diastolic Blood Pressure

    Time frame: Week 1 through Week 26

    Mean Change: vital sign value at observation minus vital sign value at baseline

  11. Mean Change From Baseline in Standing Pulse Rates

    Time frame: Week 1 through Week 26

    Mean Change: vital sign value at observation minus vital sign value at baseline

  12. Mean Change From Baseline for Body Weight

    Time frame: Week 6, Week 26

    Mean change; body weight value at observation minus body weight value at baseline.

  13. Mean Change From Baseline for Body Mass Index (BMI) Z-Score

    Time frame: Week 6, 26, early termination

    mean change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change

  14. Body Mass Index (BMI) Z-score Frequency

    Time frame: Week 6

    change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change

  15. Body Mass Index (BMI) Z-score Frequency

    Time frame: Week 26

    change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change

  16. Mean Change From Baseline for QTcF Intervals

    Time frame: Baseline to Week 26 (end of study)

    QT intervals (observed in an electrocardiogram)corrected using Fridericia's formula (QTcF). Mean change: mean change of observation minus baseline. Baseline: last available observation in the parent double-blind study.

  17. Frequency of Largest Categorical Increases in QTcF for Males

    Time frame: Week 26 (end of study)

    QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.

  18. Frequency of Largest Categorical Increases in QTcF for Females

    Time frame: Week 26 (end of study)

    QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.

  19. Frequency of Largest Categorical Increases in QTcF - All Subjects

    Time frame: Week 26 (end of study)

    QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 14, 2005
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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