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

Last updated: March 5, 2025
Sponsor: Meyer Children's Hospital IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mood Disorders

Affective Disorders

Schizophrenia And Schizoaffective Disorders (Pediatric)

Treatment

N/A

Clinical Study ID

NCT06870006
PDP-QT
  • Ages < 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Admitted to psychiatry ward

  • Starting a psychotropic drug acting on QT interval

Exclusion

Exclusion Criteria:

  • Age >18aa

  • History of administration of drug acting on QT interval in the 3 months prior

Study Design

Total Participants: 100
Study Start date:
January 01, 2024
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • AOU Meyer IRCCS

    Florence, FI 50139
    Italy

    Active - Recruiting

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