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RECRUITING
NCT06870006

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

Sponsor: Meyer Children's Hospital IRCCS

View on ClinicalTrials.gov

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

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