Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population

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.

NCT Number	NCT06870006
Lead Sponsor	Meyer Children's Hospital IRCCS
Conditions	Eating Disorders, Mood Disorders in Children and Adolescents, Psychotic Disorder, QTc Intervals Changes
Enrollment	100 participants
Start Date	2024-01-01
Primary Completion	2027-01 (estimated)
Study Completion	2027-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-18