Status:
COMPLETED
Evaluation of QTc Interval by Continuous Holter ECG Recording in Antipsychotic Drug-treated Patients With Schizophrenia
Lead Sponsor:
Northwestern University
Conditions:
Schizophrenia
Schizoaffective
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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).
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Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00178958
Start Date
August 1 2003
End Date
June 1 2006
Last Update
June 7 2017
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