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Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Extended-release carbamazepine
Sponsored by
Validus Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: DSM-IV criteria for bipolar I disorder Screen YMRS score => 16 Women of childbearing potential agree to take adequate precautions against contraception Exclusion Criteria: Hospitalization required for treatment of psychiatric symptoms Patients who meet DSM-IV for ultra-rapid cycling History of serious suicide attempt requiring medical intervention

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Score on Young Mania Rating Scale (YMRS) at 12 weeks

    Secondary Outcome Measures

    Time to remission
    Clinical Global Impressions Scale - Bipolar Version
    HAM-D and MADRS scales for depression

    Full Information

    First Posted
    September 6, 2005
    Last Updated
    November 1, 2007
    Sponsor
    Validus Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00150553
    Brief Title
    Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
    Official Title
    A Phase IIIb, Randomized, Double-Blind, Parallel Group Study in Bipolar I Patients to Assess the Efficacy and Safety of SPD417 Administered Once Daily vs Twice Daily in the Treatment of Manic Symptoms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Validus Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    102 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Extended-release carbamazepine
    Primary Outcome Measure Information:
    Title
    Score on Young Mania Rating Scale (YMRS) at 12 weeks
    Secondary Outcome Measure Information:
    Title
    Time to remission
    Title
    Clinical Global Impressions Scale - Bipolar Version
    Title
    HAM-D and MADRS scales for depression

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: DSM-IV criteria for bipolar I disorder Screen YMRS score => 16 Women of childbearing potential agree to take adequate precautions against contraception Exclusion Criteria: Hospitalization required for treatment of psychiatric symptoms Patients who meet DSM-IV for ultra-rapid cycling History of serious suicide attempt requiring medical intervention

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder

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