Open-label Adjunctive Zonisamide for Bipolar Disorder

Sponsor
Elan Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT00047567
Collaborator
(none)
20

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jul 1, 2002
Study Completion Date :
Jul 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • Bipolar I/II

    • Average intelligence

    • Taking at least one, but no more than two mood stabilizers

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Elan Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00047567
    Other Study ID Numbers:
    • ELN-345-509
    First Posted:
    Oct 10, 2002
    Last Update Posted:
    Dec 14, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 14, 2015