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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06870006
Enrollment
100
Registered
2025-03-11
Start date
2024-01-01
Completion date
2027-01-01
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

QTc interval, psychotropic drugs

Brief 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.

Interventions

None listed

Sponsors

Meyer Children's Hospital IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes in QT intervalBaseline, 1, 3, 6, 12, 18 months post- enrollment

Secondary

MeasureTime frame
Number of Cardiac eventsBaseline, 1, 3, 6, 12, 18 months post- enrollment

Countries

Italy

Contacts

CONTACTTiziana Pisano, MD
tiziana.pisano@meyer.it3498705830

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026