Monitoring heart rhythm changes in children taking psychotropic medications
Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 6 sites (Troina, Enna and 5 other locations) |
| Trial ID | NCT06870006 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Troina, Enna and 5 other locations
- Neuropsichiatria Infantile, IRCCS - OC Associazione Oasi Maria SS. ONLUS — Troina, Enna, Italy (Not_yet_recruiting)
- AOU Meyer IRCCS — Florence, Fi, Italy (Recruiting)
- IRCCS Fondazione Stella Maris — Calambrone, Pisa, Italy (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.