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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorMeyer Children's Hospital IRCCS

About this trial

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

Qualifiers

Admitted to psychiatry ward

Starting a psychotropic drug acting on QT interval

Disqualifiers

Age >18aa

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

100 Participants
are grouped into 3 trial groups