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

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178958
First received: September 12, 2005
Last updated: October 3, 2007
Last verified: October 2007
History of Changes
  Purpose

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 Intervention
Schizophrenia
Schizoaffective
Bipolar Disorder
 Device: Holter Monitor

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

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.

Estimated Enrollment: 70
Study Start Date: August 2003
Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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), fluroquinolones, or antiarrhythmics (e.g. quinidine, procainamide, amiodarone, sotalol).

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178958

Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Herbert Y Meltzer, M.D. Vanderbilt University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00178958     History of Changes
Other Study ID Numbers: 030459
Study First Received: September 12, 2005
Last Updated: October 3, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 21, 2013