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Patient-reported Outcomes in the Treatment of Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
bifeprunox
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participate in S1543003 and S1543004 in the U.S. sites Exclusion Criteria: Participate in S1543003 and S1543004 other than U.S. sites

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    September 11, 2013
    Sponsor
    Solvay Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00230828
    Brief Title
    Patient-reported Outcomes in the Treatment of Schizophrenia
    Official Title
    Patient-reported Outcomes With Bifeprunox or Olanzapine in the Treatment of Schizophrenia. A Pharmacoeconomic Study Carried Out in Connection With the S1543003 And S1543004 Clinical Trials
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    January 2006 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Solvay Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    Patient-reported health economic outcomes for patients enrolled in S1543003 and S1543004 protocols

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Non-Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    bifeprunox

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participate in S1543003 and S1543004 in the U.S. sites Exclusion Criteria: Participate in S1543003 and S1543004 other than U.S. sites
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Global Clinical Director Solvay
    Organizational Affiliation
    Solvay Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Patient-reported Outcomes in the Treatment of Schizophrenia

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