Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population
Recruiting · NCT06870006 · Observational (researchers observe without assigning treatment) · Lead sponsor: Meyer Children's Hospital IRCCS
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- Admitted to psychiatry ward
- Starting a psychotropic drug acting on QT interval
Exclusion criteria
- Age \>18aa
- History of administration of drug acting on QT interval in the 3 months prior
Where it is running
6 locations listed.
- 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
- 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