Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population
NCT ID: NCT06870006
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-01-01
2027-01-31
Brief Summary
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The study aims to investigate the incidence of QTc prolongation events as a side effect of chronic psychotropic drug administration. For this purpose, ECGs will be recorded and confounding factors of patients at the beginning of psychotropic therapy and after 3, 6 and 12 months will be analyzed.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Monotherapy
Patients taking only one drug acting on QT interval
No interventions assigned to this group
Monotherapy to monotherapy
Patients who have switched from a drug acting on QT interval to another
No interventions assigned to this group
Polytherapy
Patients taking more than one drug acting on QT interval
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Starting a psychotropic drug acting on QT interval
Exclusion Criteria
* History of administration of drug acting on QT interval in the 3 months prior
18 Years
ALL
No
Sponsors
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Meyer Children's Hospital IRCCS
OTHER
Responsible Party
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Locations
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AOU Meyer IRCCS
Florence, FI, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PDP-QT
Identifier Type: -
Identifier Source: org_study_id
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