Eating DisordersNCT06870006
Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population
An observational study of Eating Disorders and Mood Disorders in Children and Adolescents, run by Meyer Children's Hospital IRCCS at 6 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Eating Disorders, Mood Disorders in Children and Adolescents, Psychotic Disorder
- How many people
- 100 participants
- Where
- 6 sitesItaly
- Study dates
- 1 Jan 2024to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Admitted to psychiatry ward
- Starting a psychotropic drug acting on QT interval
Who cannot join
- Age >18aa
- History of administration of drug acting on QT interval in the 3 months prior
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Italy6 sites, 5 recruiting
- Active, not recruiting
Neuropsichiatria infantile, Policlinico S.Orsola-Malpighi
Bologna, 40138
- Not yet recruiting
Clinica di Neuropsichiatria dell'Infanzia e dell'adolescenza, Ospedale Pediatrico A. Cao ARNAS G. Brotzu
Cagliari, 09121
- Recruiting
IRCCS Fondazione Stella Maris
Calambrone, Pisa, 56128
- Recruiting
AOU Meyer IRCCS
Florence, FI, 50139
Tiziana Pisano, MD, 3498705830, tiziana.pisano@meyer.it
- Not yet recruiting
Neuropsichiatria Infantile, Azienda Ospedaliera-Universitaria "Gaetano Martino"
Messina, 98124
- Not yet recruiting
Neuropsichiatria Infantile, IRCCS - OC Associazione Oasi Maria SS. ONLUS
Troina, Enna, 94018
About this study
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
- Medical subject headings
- Feeding and Eating Disorders, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Changes in QT interval
Measured: Baseline, 1, 3, 6, 12, 18 months post- enrollment
Secondary outcomes (1)
Number of Cardiac events
Measured: Baseline, 1, 3, 6, 12, 18 months post- enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Jan 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870006
- Sponsor's protocol ID
- PDP-QT
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population
- ClinicalTrials.gov ID
- NCT06870006
- Acronym / sponsor ID
- PDP-QT
- Conditions
- Eating Disorders, Mood Disorders in Children and Adolescents, Psychotic Disorder, QTc Intervals Changes
- Keywords
- QTc interval, psychotropic drugs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Admitted to psychiatry ward
- Starting a psychotropic drug acting on QT interval
Key exclusion criteria (2 listed)
- Age >18aa
- History of administration of drug acting on QT interval in the 3 months prior
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in QT interval
Time frame: Baseline, 1, 3, 6, 12, 18 months post- enrollment
1 secondary outcome
Number of Cardiac events
Time frame: Baseline, 1, 3, 6, 12, 18 months post- enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders and Mood Disorders in Children and Adolescents, run by Meyer Children's Hospital IRCCS at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiziana Pisano, MD (3498705830 ext. +39, tiziana.pisano@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in QT interval (time frame: Baseline, 1, 3, 6, 12, 18 months post- enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.