NCT06870006 Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population
| NCT ID | NCT06870006 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Meyer Children's Hospital IRCCS |
| Condition | Eating Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-01-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06870006 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Eating Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06870006 currently recruiting?
Yes, NCT06870006 is actively recruiting participants. Contact the research team at tiziana.pisano@meyer.it for enrollment information.
Where is the NCT06870006 trial being conducted?
This trial is being conducted at Troina, Italy, Florence, Italy, Calambrone, Italy, Bologna, Italy and 2 additional locations.
Who is sponsoring the NCT06870006 clinical trial?
NCT06870006 is sponsored by Meyer Children's Hospital IRCCS. The trial plans to enroll 100 participants.