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

March 17, 2026 updated by: Meyer Children's Hospital IRCCS

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Active, not recruiting
        • Neuropsichiatria infantile, Policlinico S.Orsola-Malpighi
      • Cagliari, Italy, 09121
        • Not yet recruiting
        • Clinica di Neuropsichiatria dell'Infanzia e dell'adolescenza, Ospedale Pediatrico A. Cao ARNAS G. Brotzu
      • Messina, Italy, 98124
        • Not yet recruiting
        • Neuropsichiatria Infantile, Azienda Ospedaliera-Universitaria "Gaetano Martino"
    • Enna
      • Troina, Enna, Italy, 94018
        • Not yet recruiting
        • Neuropsichiatria Infantile, IRCCS - OC Associazione Oasi Maria SS. ONLUS
    • FI
      • Florence, FI, Italy, 50139
    • Pisa
      • Calambrone, Pisa, Italy, 56128
        • Recruiting
        • IRCCS Fondazione Stella Maris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children and adolescents referring to psychiatry services in one the participating hospitals starting a new prescription for a psychotropic drug acting on QT interval.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Monotherapy
Patients taking only one drug acting on QT interval
Monotherapy to monotherapy
Patients who have switched from a drug acting on QT interval to another
Polytherapy
Patients taking more than one drug acting on QT interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in QT interval
Time Frame: Baseline, 1, 3, 6, 12, 18 months post- enrollment
Baseline, 1, 3, 6, 12, 18 months post- enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Cardiac events
Time Frame: Baseline, 1, 3, 6, 12, 18 months post- enrollment
Baseline, 1, 3, 6, 12, 18 months post- enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meyer Children's Hospital IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDP-QT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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