Psychotropic-Drug-induced QT Prolongation and ECG Monitor... | NCT06870006

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

NCT06870006

Sponsor

Meyer Children's Hospital IRCCS

Status

Recruiting

Last Update Posted

Mar 18, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Jan 2027Estimated

Completion Date

Jan 2027Estimated

First Submitted Date

Feb 27, 2025

First Submission Date that Met QC Criteria

Mar 5, 2025

First Posted Date

Mar 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2026

Last Update Posted Date

Mar 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tiziana Pisano, MD	Contact	3498705830	+39	tiziana.pisano@meyer.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neuropsichiatria Infantile, IRCCS - OC Associazione Oasi Maria SS. ONLUS	Not yet recruiting	Troina	Enna	94018	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001068	Feeding and Eating Disorders
D011618	Psychotic Disorders

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided