Actively Recruiting
Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population
Led by Meyer Children's Hospital IRCCS · Updated on 2026-03-18
100
Participants Needed
6
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted to psychiatry ward
- Starting a psychotropic drug acting on QT interval
You will not qualify if you...
- Older than 18 years
- History of taking drugs affecting QT interval in the 3 months prior
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Neuropsichiatria Infantile, IRCCS - OC Associazione Oasi Maria SS. ONLUS
Troina, Enna, Italy, 94018
Not Yet Recruiting
2
AOU Meyer IRCCS
Florence, FI, Italy, 50139
Actively Recruiting
3
IRCCS Fondazione Stella Maris
Calambrone, Pisa, Italy, 56128
Actively Recruiting
4
Neuropsichiatria infantile, Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138
Active, Not Recruiting
5
Clinica di Neuropsichiatria dell'Infanzia e dell'adolescenza, Ospedale Pediatrico A. Cao ARNAS G. Brotzu
Cagliari, Italy, 09121
Not Yet Recruiting
6
Neuropsichiatria Infantile, Azienda Ospedaliera-Universitaria "Gaetano Martino"
Messina, Italy, 98124
Not Yet Recruiting
Research Team
T
Tiziana Pisano, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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