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Evaluation of QTc Interval by Continuous Holter ECG Recording in Antipsychotic Drug-treated Patients With Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Holter Monitor
Sponsored by
Northwestern University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects will be males or females between 18 - 65 years of age. Patient subjects will have a definite diagnosis by DSM-IV criteria, schizophrenia, schizoaffective disorder, or bipolar disorder. Patient subjects are currently under treatment with any antipsychotic, any mood stabilizer, any antidepressant or any combination of the above at the therapeutic dose for at least 3 months. Patients have a history of taking the medications listed in item 3 as prescribed. The subjects must be able to provide written informed consent Exclusion Criteria: Subjects with a DSM-IV diagnosis of substance dependence as defined by DSMN within three months prior to selection. Subjects who are currently taking other medications that have been shown to prolong the QTc, including tricyclic antidepressants (e.g. amitriptyline, imipramine, maprotiline), fluoroquinolones, or antiarrhythmics (e.g. quinidine, procainamide, amiodarone, sotalol). -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The aim of this study is to evaluate the utility of continuous Holter ECG recording with automated, computerized data analysis for measuring antipsychotic-related QTc prolongation during a 24-h period under clinical conditions.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    June 5, 2017
    Sponsor
    Northwestern University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00178958
    Brief Title
    Evaluation of QTc Interval by Continuous Holter ECG Recording in Antipsychotic Drug-treated Patients With Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwestern University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate the utility of continuous Holter ECG recording with automated, computerized data analysis for measuring antipsychotic-related QTc prolongation during a 24-h period under clinical conditions

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    70 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Holter Monitor
    Primary Outcome Measure Information:
    Title
    The aim of this study is to evaluate the utility of continuous Holter ECG recording with automated, computerized data analysis for measuring antipsychotic-related QTc prolongation during a 24-h period under clinical conditions.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjects will be males or females between 18 - 65 years of age. Patient subjects will have a definite diagnosis by DSM-IV criteria, schizophrenia, schizoaffective disorder, or bipolar disorder. Patient subjects are currently under treatment with any antipsychotic, any mood stabilizer, any antidepressant or any combination of the above at the therapeutic dose for at least 3 months. Patients have a history of taking the medications listed in item 3 as prescribed. The subjects must be able to provide written informed consent Exclusion Criteria: Subjects with a DSM-IV diagnosis of substance dependence as defined by DSMN within three months prior to selection. Subjects who are currently taking other medications that have been shown to prolong the QTc, including tricyclic antidepressants (e.g. amitriptyline, imipramine, maprotiline), fluoroquinolones, or antiarrhythmics (e.g. quinidine, procainamide, amiodarone, sotalol). -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Herbert Y Meltzer, M.D.
    Organizational Affiliation
    Vanderbilt University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of QTc Interval by Continuous Holter ECG Recording in Antipsychotic Drug-treated Patients With Schizophrenia

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