Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-02 @ 8:19 AM
Study NCT ID:
NCT03642405
Status:
UNKNOWN
Last Update Posted:
2019-01-03
First Post:
2018-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-induced Repolarization ECG Changes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008133', 'term': 'Long QT Syndrome'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D029597', 'term': 'Romano-Ward Syndrome'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-02', 'studyFirstSubmitDate': '2018-08-16', 'studyFirstSubmitQcDate': '2018-08-20', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ECG changes', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'The Primary Outcome assess whether there are changes on ECG, primary the QTc-interval, in participants receiving medication for ADHD and depression.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Long QT Syndrome', 'ADHD', 'Depression', 'Death', 'Death, Sudden, Cardiac', 'Romano-Ward Syndrome', 'Pathologic Processes', 'Heart Arrest', 'Electrocardiogram: Electrical Alternans', 'Heart Diseases', 'Cardiovascular Diseases', 'Death, Sudden', 'Arrhythmias, Cardiac', 'Heart Defects, Congenital', 'Cardiovascular Abnormalities', 'Congenital Abnormalities', 'Genetic Disease', 'Genetic Syndrome', 'Qt Interval, Variation in', 'Psychiatric Disorder']}, 'descriptionModule': {'briefSummary': 'Studies have shown that the risk of developing heart arrhythmias, is increased in patients receiving medication for Attention-deficit hyperactivity disorder (ADHD) and depression. The QT-interval on a electrocardiogram (ECG) is often used to assess the patients risk of developing heart arrhythmias. The QT-interval defines the hearts electrical resting period and a long interval is linked to an increased risk of developing heart arrhythmias. In this project the investigators wish to examine possible side-effects in patients receiving medication for ADHD and depression and their dynamic QT-interval changes, by analysing the ECG changes that occur during "Brisk Standing".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 Patients treated with Methylphenidate 50 Patients treated with Methylphenidate and QT-prolonging SSRI 50 Patients treated with Methylphenidate and a non QT-prolonging SSRI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years old\n* Patients treated with Methylphenidate\n* Patients treated with Methylphenidate and QT-prolonging SSRI\n* Patients treated with Methylphenidate and a non QT-prolonging SSRI\n\nExclusion Criteria:\n\n* Patients considered in an unstable phase in their psychiatric condition\n* Patients that are not able to understand the information regarding the trial, or who are unable to cooperate.'}, 'identificationModule': {'nctId': 'NCT03642405', 'briefTitle': 'Drug-induced Repolarization ECG Changes', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital at Herlev'}, 'officialTitle': 'Exploring the Effect of Methylphenidate and Antidepressants on Cardiac Repolarisation.', 'orgStudyIdInfo': {'id': 'HerlevH01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Methylphenidate-Group', 'description': 'The group is examined before and after intake of Methylphenidate', 'interventionNames': ['Diagnostic Test: Electrocardiogram examination', 'Diagnostic Test: Echocardiography', 'Procedure: Blood Samples', 'Behavioral: Questionnaire']}, {'label': 'Methylphenidate and know QT-prolonging SSRI', 'description': 'The group is examined before and after intake of Methylphenidate', 'interventionNames': ['Diagnostic Test: Electrocardiogram examination', 'Diagnostic Test: Echocardiography', 'Procedure: Blood Samples', 'Behavioral: Questionnaire']}, {'label': 'Methylphenidate and non-QT-prolonging SSRI', 'description': 'The group is examined before and after intake of Methylphenidate', 'interventionNames': ['Diagnostic Test: Electrocardiogram examination', 'Diagnostic Test: Echocardiography', 'Procedure: Blood Samples', 'Behavioral: Questionnaire']}], 'interventions': [{'name': 'Electrocardiogram examination', 'type': 'DIAGNOSTIC_TEST', 'description': '12-lead ECG monitored by Holter', 'armGroupLabels': ['Methylphenidate and know QT-prolonging SSRI', 'Methylphenidate and non-QT-prolonging SSRI', 'Methylphenidate-Group']}, {'name': 'Echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Echocardiography in accordance to Danish Society of Cardiology', 'armGroupLabels': ['Methylphenidate and know QT-prolonging SSRI', 'Methylphenidate and non-QT-prolonging SSRI', 'Methylphenidate-Group']}, {'name': 'Blood Samples', 'type': 'PROCEDURE', 'description': 'Blood Samples include, Genetic analysis, serum-Methylphenidate, serum-Citalopram. Sodium, Potassium, Magnesium, Calcium, Chloride, White-Blood-Count, Hemoglobin, C-reactive-Protein, Creatinine, Carbamide, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), Glucose and pro-brain natriuretic peptide (Pro-BNP).', 'armGroupLabels': ['Methylphenidate and know QT-prolonging SSRI', 'Methylphenidate and non-QT-prolonging SSRI', 'Methylphenidate-Group']}, {'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'description': 'Questionnaire regarding patients quality of life', 'armGroupLabels': ['Methylphenidate and know QT-prolonging SSRI', 'Methylphenidate and non-QT-prolonging SSRI', 'Methylphenidate-Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD research fellow (Ph.D)', 'investigatorFullName': 'Peter Marstrand', 'investigatorAffiliation': 'Copenhagen University Hospital at Herlev'}}}}