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NCT Number: NCT06870006

Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population

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.

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Key information

Conditions

Eating Disorders Feeding and Eating Disorders Mental Disorders Mood Disorders in Children and Adolescents Pathological Conditions, Signs and Symptoms Psychotic Disorder Psychotic Disorders QTc Intervals Changes Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Signs and Symptoms, Digestive

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Neuropsichiatria Infantile, IRCCS - OC Associazione Oasi Maria SS. ONLUS, Troina, Enna, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Changes in QT interval

    Time frame: Baseline, 1, 3, 6, 12, 18 months post- enrollment

Secondary outcomes

  1. Number of Cardiac events

    Time frame: Baseline, 1, 3, 6, 12, 18 months post- enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Tiziana Pisano, MD

CONTACT

[email protected]

3498705830 ext. +39

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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