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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 (Responsible Party):
Herbert Meltzer, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178958
First received: September 12, 2005
Last updated: June 5, 2017
Last verified: June 2017
  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
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Herbert Meltzer, 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   (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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Responsible Party: Herbert Meltzer, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00178958     History of Changes
Other Study ID Numbers: 030459
Study First Received: September 12, 2005
Last Updated: June 5, 2017

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

ClinicalTrials.gov processed this record on July 26, 2017