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Clinical Trials in Italy / NCT06870006
Recruiting Observational

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

NCT06870006 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-01-01
Last updated
2026-03-18

Condition(s) studied

Eating DisordersMood Disorders in Children and AdolescentsPsychotic DisorderQTc Intervals Changes

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Neuropsichiatria Infantile, IRCCS - OC Associazione Oasi Maria SS. ONLUS Troina Enna Not Yet Recruiting
AOU Meyer IRCCS Florence FI Recruiting
IRCCS Fondazione Stella Maris Calambrone Pisa Recruiting
Neuropsichiatria infantile, Policlinico S.Orsola-Malpighi Bologna Italy Active Not Recruiting
Clinica di Neuropsichiatria dell'Infanzia e dell'adolescenza, Ospedale Pediatrico A. Cao ARNAS G. Brotzu Cagliari Italy Not Yet Recruiting
Neuropsichiatria Infantile, Azienda Ospedaliera-Universitaria "Gaetano Martino" Messina Italy Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06870006 on ClinicalTrials.gov ↗ ← All trials in Italy