Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-01-01 @ 6:22 AM
Study NCT ID:
NCT06870006
Status:
RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in QT interval', 'timeFrame': 'Baseline, 1, 3, 6, 12, 18 months post- enrollment'}], 'secondaryOutcomes': [{'measure': 'Number of Cardiac events', 'timeFrame': 'Baseline, 1, 3, 6, 12, 18 months post- enrollment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['QTc interval', 'psychotropic drugs'], 'conditions': ['Eating Disorders', 'Mood Disorders in Children and Adolescents', 'Psychotic Disorder', 'QTc Intervals Changes']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adolescents referring to psychiatry services in one the participating hospitals starting a new prescription for a psychotropic drug acting on QT interval.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to psychiatry ward\n* Starting a psychotropic drug acting on QT interval\n\nExclusion Criteria:\n\n* Age \\>18aa\n* History of administration of drug acting on QT interval in the 3 months prior'}, 'identificationModule': {'nctId': 'NCT06870006', 'briefTitle': 'Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population', 'organization': {'class': 'OTHER', 'fullName': "Meyer Children's Hospital IRCCS"}, 'officialTitle': 'Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population', 'orgStudyIdInfo': {'id': 'PDP-QT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Monotherapy', 'description': 'Patients taking only one drug acting on QT interval'}, {'label': 'Monotherapy to monotherapy', 'description': 'Patients who have switched from a drug acting on QT interval to another'}, {'label': 'Polytherapy', 'description': 'Patients taking more than one drug acting on QT interval'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50139', 'city': 'Florence', 'state': 'FI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Tiziana Pisano, MD', 'role': 'CONTACT', 'email': 'tiziana.pisano@meyer.it', 'phone': '3498705830'}], 'facility': 'AOU Meyer IRCCS', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}], 'centralContacts': [{'name': 'Tiziana Pisano, MD', 'role': 'CONTACT', 'email': 'tiziana.pisano@meyer.it', 'phone': '3498705830', 'phoneExt': '+39'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Meyer Children's Hospital IRCCS", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}