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

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

Recruiting
18 years and younger
All
Phase N/A

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Overview

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

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

Study details
    Eating Disorders
    Mood Disorders in Children and Adolescents
    Psychotic Disorder
    QTc Intervals Changes

NCT06870006

Meyer Children's Hospital IRCCS

15 October 2025

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