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

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ClinicalTrials.gov Identifier: NCT00178958
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Herbert Meltzer, Vanderbilt University

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

Condition or disease Intervention/treatment
Schizophrenia Schizoaffective Bipolar Disorder Device: Holter Monitor

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : August 2003
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources




Primary Outcome Measures :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects will be males or females between 18 - 65 years of age.
  2. Patient subjects will have a definite diagnosis by DSM-IV criteria, schizophrenia, schizoaffective disorder, or bipolar disorder.
  3. 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.
  4. Patients have a history of taking the medications listed in item 3 as prescribed.
  5. The subjects must be able to provide written informed consent

Exclusion Criteria:

  1. Subjects with a DSM-IV diagnosis of substance dependence as defined by DSMN within three months prior to selection.
  2. 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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178958


Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Herbert Y Meltzer, M.D. Vanderbilt University Medical Center

Responsible Party: Herbert Meltzer, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00178958     History of Changes
Other Study ID Numbers: 030459
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders