An observational study in Eating Disorders, Mood Disorders in Children and Adolescents and Psychotic Disorder, sponsored by Meyer Children's Hospital IRCCS. Recruiting at 6 sites in Italy. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Meyer Children's Hospital IRCCS · Observational
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.
645 studies on the registry are indexed under Feeding and Eating Disorders; 153 are open to participants now.
This study's planned enrollment of 100 is close to the median of 102 across 177 observational studies indexed under Feeding and Eating Disorders.
Browse Feeding and Eating Disorders studies →Meyer Children's Hospital IRCCS is the lead sponsor of 78 studies on the registry; 55 are open to participants now.
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Children and adolescents referring to psychiatry services in one the participating hospitals starting a new prescription for a psychotropic drug acting on QT interval.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients taking only one drug acting on QT interval
Patients who have switched from a drug acting on QT interval to another
Patients taking more than one drug acting on QT interval
Changes in QT interval
Time frame: Baseline, 1, 3, 6, 12, 18 months post- enrollment
Number of Cardiac events
Time frame: Baseline, 1, 3, 6, 12, 18 months post- enrollment
Not enrolling at this site.
Plan to share: Undecided
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