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Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01117220
Collaborator
(none)
0
Enrollment
2
Arms
10
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with Bipolar l Disorder (Manic or Mixed).

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: Ziprasidone Oral Capsules
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Four Week, Double Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Study Start Date :
Jun 1, 2010
Anticipated Primary Completion Date :
Apr 1, 2011
Anticipated Study Completion Date :
Apr 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 2

Drug: Placebo
Placebo matching the oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dose design with minimal dose range of 40 mg twice a day (BID) to maximum dose range of 80 mg BID (weight specific- < 45kg max dose 40 mg BID).
Active Comparator: 1

Drug: Ziprasidone Oral Capsules
Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dose design with minimal dose range of 40 mg twice a day (BID to maximum dose range of 80 mg BID (weight specific- < 45kg max dose 40 mg BID).
Other Names:
  • Geodon, Zeldox

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline to Week 4 in Young Mania Rating Scale (YMRS) total score. [4 weeks]

    Secondary Outcome Measures

    1. Change from baseline in Clinical Global Impression of Severity (CGI S) score. [4 weeks]

    2. Clinical Global Impression of Improvement (CGI I) score [4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for Bipolar I disorder (manic or mixed)

    • At the screening and baseline visits, subjects must have a Young Mania Rating Scale (YMRS) score of at least 17.

    • The subject must have a Body Mass Index (BMI) z score between -1.65 and +2.00, inclusive

    Exclusion Criteria:

    • Imminent risk of suicide or homicide, as judged by the site investigator

    • Any history of serious or unstable illness

    • Risk for prolonged QT

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    ClinicalTrials.gov Identifier:
    NCT01117220
    Other Study ID Numbers:
    • A1281196
    First Posted:
    May 5, 2010
    Last Update Posted:
    Feb 21, 2021
    Last Verified:
    Feb 1, 2021
    Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
    pediatric
    bipolar
    Additional relevant MeSH terms:
    Bipolar Disorder
    Ziprasidone

    Study Results

    No Results Posted as of Feb 21, 2021