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

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178958
• Other study ID #: 030459
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: June 5, 2017
• Start date: August 2003
• Est. completion date: June 2006

Study information

• Verified date: June 2017
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bipolar Disorder
• Schizoaffective
• Schizophrenia

Intervention

Device:
• Holter Monitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.