Monitoring heart rhythm changes in children taking psychotropic medications
Official title: Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population
Run by Meyer Children's Hospital IRCCS · NCT06870006 · Data updated 2026-11-12
This study looks at how often heart rhythm changes happen in kids and teens taking mental health medications to see when they should have heart checks to keep them safe.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 6 sites (Troina, Enna and 5 other locations) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | March 18, 2026 |
| Trial ID | NCT06870006 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children and adolescents who are being admitted to a psychiatry ward and are starting a new psychotropic medication that affects the QT interval.
✕Probably not a fit
Patients over the age of 18 or those who have taken a QT interval-affecting drug in the past three months will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the incidence of QTc prolongation, a potential cardiac side effect, in children and adolescents who are prescribed psychotropic medications. It involves recording electrocardiograms (ECGs) at baseline and then again at 3, 6, and 12 months after starting treatment. The study aims to identify when ECG monitoring should be repeated during clinical follow-up to ensure patient safety. By analyzing the data, researchers hope to establish better protocols for ECG monitoring in this vulnerable population.
Why it matters
Potential benefit: If successful, this study could lead to improved safety protocols for monitoring heart health in children taking psychotropic medications.
How similar studies have gone: While there is limited data on similar studies, the investigation of QT prolongation in pediatric populations taking psychotropic drugs is an important area of research that has not been extensively validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
AOU Meyer IRCCS
Florence, Fi, Italy Recruiting -
IRCCS Fondazione Stella Maris
Calambrone, Pisa, Italy Recruiting -
Neuropsichiatria Infantile, IRCCS - OC Associazione Oasi Maria SS. ONLUS
Troina, Enna, Italy Not yet recruiting -
Neuropsichiatria infantile, Policlinico S.Orsola-Malpighi
Bologna, Italy Active not recruiting -
Clinica di Neuropsichiatria dell'Infanzia e dell'adolescenza, Ospedale Pediatrico A. Cao ARNAS G. Brotzu
Cagliari, Italy Not yet recruiting -
Neuropsichiatria Infantile, Azienda Ospedaliera-Universitaria "Gaetano Martino"
Messina, Italy Not yet recruiting
Study contacts
- Study coordinator: Tiziana Pisano, MD
- Email: tiziana.pisano@meyer.it
- Phone: 3498705830
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.