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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00265330
First received: December 12, 2005
Last updated: December 2, 2011
Last verified: December 2011
  Purpose

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)


Condition Intervention Phase
Bipolar Disorder
Drug: Ziprasidone oral capsules
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Young Mania Rating Scale (YMRS) Total Score Change From Baseline [ Time Frame: baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF) ] [ Designated as safety issue: No ]
    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.

  • Clinical Global Impression of Severity (CGI-S) Change From Baseline [ Time Frame: baseline and 26 Weeks; 26 Weeks LOCF ] [ Designated as safety issue: No ]
    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).

  • Incidence of Lab Abnormalities [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
    number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality.

  • Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol [ Time Frame: Week 6, Week 26 ] [ Designated as safety issue: Yes ]
    Mean Change: lab value at observation minus lab value at baseline.

  • Change in Hormones [ Time Frame: Week 6, Week 26 ] [ Designated as safety issue: Yes ]
    Mean Change: lab value at observation minus lab value at baseline

  • Mean Change From Baseline in Supine Systolic Blood Pressure [ Time Frame: Week 1 through Week 26 ] [ Designated as safety issue: Yes ]
    Mean Change: vital sign value at observation minus vital sign value at baseline

  • Mean Change From Baseline in Supine Diastolic Blood Pressure [ Time Frame: Week 1 through Week 26 ] [ Designated as safety issue: Yes ]
    Mean Change: vital sign value at observation minus vital sign value at baseline

  • Mean Change From Baseline in Supine Pulse Rates [ Time Frame: Week 1 through Week 26 ] [ Designated as safety issue: Yes ]
    Mean Change: vital sign value at observation minus vital sign value at baseline

  • Mean Change From Baseline in Standing Systolic Blood Pressure [ Time Frame: Week 1 through Week 26 ] [ Designated as safety issue: Yes ]
    Mean Change: vital sign value at observation minus vital sign value at baseline

  • Mean Change From Baseline in Standing Diastolic Blood Pressure [ Time Frame: Week 1 through Week 26 ] [ Designated as safety issue: Yes ]
    Mean Change: vital sign value at observation minus vital sign value at baseline

  • Mean Change From Baseline in Standing Pulse Rates [ Time Frame: Week 1 through Week 26 ] [ Designated as safety issue: Yes ]
    Mean Change: vital sign value at observation minus vital sign value at baseline

  • Mean Change From Baseline for Body Weight [ Time Frame: Week 6, Week 26 ] [ Designated as safety issue: Yes ]
    Mean change; body weight value at observation minus body weight value at baseline.

  • Mean Change From Baseline for Body Mass Index (BMI) Z-Score [ Time Frame: Week 6, 26, early termination ] [ Designated as safety issue: Yes ]
    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

  • Body Mass Index (BMI) Z-score Frequency [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
    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

  • Body Mass Index (BMI) Z-score Frequency [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]
    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

  • Mean Change From Baseline for QTcF Intervals [ Time Frame: Baseline to Week 26 (end of study) ] [ Designated as safety issue: Yes ]
    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.

  • Frequency of Largest Categorical Increases in QTcF for Males [ Time Frame: Week 26 (end of study) ] [ Designated as safety issue: Yes ]
    QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.

  • Frequency of Largest Categorical Increases in QTcF for Females [ Time Frame: Week 26 (end of study) ] [ Designated as safety issue: Yes ]
    QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.

  • Frequency of Largest Categorical Increases in QTcF - All Subjects [ Time Frame: Week 26 (end of study) ] [ Designated as safety issue: Yes ]
    QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.


Enrollment: 169
Study Start Date: March 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Drug: Ziprasidone oral capsules
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 .

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265330

  Show 41 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00265330     History of Changes
Other Study ID Numbers: A1281133
Study First Received: December 12, 2005
Results First Received: January 22, 2009
Last Updated: December 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 24, 2014