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

NCT06870006 | Recruiting

• 1 other identifier: PDP-QT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 6

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.

Conditions

Eating Disorders; Mood Disorders in Children and Adolescents; Psychotic Disorder; QTc Intervals Changes

Keywords

QTc interval; psychotropic drugs

Outcome Measures

Primary Outcomes (1)

• Changes in QT interval

  Baseline, 1, 3, 6, 12, 18 months post- enrollment

Secondary Outcomes (1)

• Number of Cardiac events

  Baseline, 1, 3, 6, 12, 18 months post- enrollment

Study Arms (3)

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Admitted to psychiatry ward
• Starting a psychotropic drug acting on QT interval

You may not qualify if:

• Age \>18aa
• History of administration of drug acting on QT interval in the 3 months prior

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (6)

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

Troina, Enna, 94018, Italy

NOT YET RECRUITING

AOU Meyer IRCCS

Florence, FI, 50139, Italy

RECRUITING

IRCCS Fondazione Stella Maris

Calambrone, Pisa, 56128, Italy

RECRUITING

Neuropsichiatria infantile, Policlinico S.Orsola-Malpighi

Bologna, 40138, Italy

ACTIVE NOT RECRUITING

Clinica di Neuropsichiatria dell'Infanzia e dell'adolescenza, Ospedale Pediatrico A. Cao ARNAS G. Brotzu

Cagliari, 09121, Italy

NOT YET RECRUITING

Neuropsichiatria Infantile, Azienda Ospedaliera-Universitaria "Gaetano Martino"

Messina, 98124, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders; Psychotic Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Central Study Contacts

Tiziana Pisano, MD

CONTACT

3498705830; tiziana.pisano@meyer.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 11, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

IT (6)