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Open-label Adjunctive Zonisamide for Bipolar Disorder

Primary Purpose

Bipolar Disorders

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
zonisamide
Sponsored by
Elan Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorders focused on measuring ZONISAMIDE, BIPOLAR

Eligibility Criteria

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

Bipolar I/II Average intelligence Taking at least one, but no more than two mood stabilizers

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 8, 2002
    Last Updated
    December 10, 2015
    Sponsor
    Elan Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00047567
    Brief Title
    Open-label Adjunctive Zonisamide for Bipolar Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    July 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2002 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Elan Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    To study the safety and efficacy of zonisamide as adjunctive therapy for children and adolescents with bipolar I or II disorder.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Disorders
    Keywords
    ZONISAMIDE, BIPOLAR

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    zonisamide

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Bipolar I/II Average intelligence Taking at least one, but no more than two mood stabilizers

    12. IPD Sharing Statement

    Learn more about this trial

    Open-label Adjunctive Zonisamide for Bipolar Disorder

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