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Heart risk in kids on psychiatric meds: new study aims for safer monitoring

NCT ID NCT06870006

Knowledge-focused Sponsor: Meyer Children's Hospital IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how certain psychiatric drugs may change heart rhythms in children and teens. Researchers will track 100 young patients with eating disorders, mood disorders, or psychosis who are starting a new psychiatric medication. They will perform ECGs at the start and after 3, 6, and 12 months to see how often dangerous heart rhythm changes occur. The goal is to create better guidelines for when to repeat heart checks during treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

Up to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

eating disorder Feeding and Eating Disorders mood disorder psychotic disorder Psychotic Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eating disorders Mood disorders in children and adolescents Psychotic disorder QTC intervals changes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Meyer IRCCS

    RECRUITING

    Florence, FI, 50139, Italy

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

    NOT_YET_RECRUITING

    Cagliari, 09121, Italy

  • IRCCS Fondazione Stella Maris

    RECRUITING

    Calambrone, Pisa, 56128, Italy

  • Neuropsichiatria Infantile, Azienda Ospedaliera-Universitaria "Gaetano Martino"

    NOT_YET_RECRUITING

    Messina, 98124, Italy

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

    NOT_YET_RECRUITING

    Troina, Enna, 94018, Italy

  • Neuropsichiatria infantile, Policlinico S.Orsola-Malpighi

    ACTIVE_NOT_RECRUITING

    Bologna, 40138, Italy

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