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Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population
Sponsor: Meyer Children's Hospital IRCCS
Summary
Electrocardiogram (ECG) Q-T prolongation is a cardiac electrophysiological disorder associated with the occurrence of arrhythmias potentially fatal. Several psychotropic drugs are associated with an increased risk of QT prolongation, which is why in clinical practice a baseline ECG is performed before a psychotropic drug is prescribed. However, there are no validated protocols establishing when to repeat this examination or describing clinical events when this examination should be repeated in clinical follow-up. 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.
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2024-01-01
Completion Date
2027-01
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Locations (6)
Neuropsichiatria Infantile, IRCCS - OC Associazione Oasi Maria SS. ONLUS
Troina, Enna, Italy
AOU Meyer IRCCS
Florence, FI, Italy
IRCCS Fondazione Stella Maris
Calambrone, Pisa, Italy
Neuropsichiatria infantile, Policlinico S.Orsola-Malpighi
Bologna, Italy
Clinica di Neuropsichiatria dell'Infanzia e dell'adolescenza, Ospedale Pediatrico A. Cao ARNAS G. Brotzu
Cagliari, Italy
Neuropsichiatria Infantile, Azienda Ospedaliera-Universitaria "Gaetano Martino"
Messina, Italy