NCT Number: NCT00178958
Evaluation of QTc Interval by Continuous Holter ECG Recording in Antipsychotic Drug-treated Patients With Schizophrenia
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
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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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Treatment and study plan
Primary outcomes
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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.
Sponsors and collaborators
Lead sponsor
Northwestern University
Other
Registry information
Important dates
- Study start
- 2003
- Study completion
- 2006
- First posted
- Sep 15, 2005
- Registry last updated
- Jun 7, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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