NCT06870006

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Meyer Children's Hospital IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2024-01-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-03-11
• Last updated: 2026-03-18

Locations

6 sites across 1 country: Italy