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

Meyer Children's Hospital IRCCS

Status: Enrolling

Conditions: QTc Intervals Changes; Eating Disorders; Psychotic Disorder; Mood Disorders in Children and Adolescents

Study type: Observational

Funder types: Other

Identifiers

NCT06870006

PDP-QT

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

Monotherapy

Description:

Patients taking only one drug acting on QT interval

Monotherapy to monotherapy

Description:

Patients who have switched from a drug acting on QT interval to another

Polytherapy

Description:

Patients taking more than one drug acting on QT interval