Drug-induced Repolarization ECG Changes

NCT03642405 | Unknown

• 1 other identifier: HerlevH01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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".

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

Outcome Measures

Primary Outcomes (1)

• ECG changes

  The Primary Outcome assess whether there are changes on ECG, primary the QTc-interval, in participants receiving medication for ADHD and depression.

  Through study completion, an average of 1 year.

Study Arms (3)

Methylphenidate-Group

The group is examined before and after intake of Methylphenidate

Diagnostic Test: Electrocardiogram examination; Diagnostic Test: Echocardiography; Procedure: Blood Samples; Behavioral: Questionnaire

Methylphenidate and know QT-prolonging SSRI

The group is examined before and after intake of Methylphenidate

Diagnostic Test: Electrocardiogram examination; Diagnostic Test: Echocardiography; Procedure: Blood Samples; Behavioral: Questionnaire

Methylphenidate and non-QT-prolonging SSRI

The group is examined before and after intake of Methylphenidate

Diagnostic Test: Electrocardiogram examination; Diagnostic Test: Echocardiography; Procedure: Blood Samples; Behavioral: Questionnaire

Interventions

Electrocardiogram examination DIAGNOSTIC_TEST

12-lead ECG monitored by Holter

Methylphenidate and know QT-prolonging SSRI; Methylphenidate and non-QT-prolonging SSRI; Methylphenidate-Group

Echocardiography DIAGNOSTIC_TEST

Echocardiography in accordance to Danish Society of Cardiology

Methylphenidate and know QT-prolonging SSRI; Methylphenidate and non-QT-prolonging SSRI; Methylphenidate-Group

Blood Samples PROCEDURE

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).

Methylphenidate and know QT-prolonging SSRI; Methylphenidate and non-QT-prolonging SSRI; Methylphenidate-Group

Questionnaire BEHAVIORAL

Questionnaire regarding patients quality of life

Methylphenidate and know QT-prolonging SSRI; Methylphenidate and non-QT-prolonging SSRI; Methylphenidate-Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Over 18 years old
• Patients treated with Methylphenidate
• Patients treated with Methylphenidate and QT-prolonging SSRI
• Patients treated with Methylphenidate and a non QT-prolonging SSRI

You may not qualify if:

• Patients considered in an unstable phase in their psychiatric condition
• Patients that are not able to understand the information regarding the trial, or who are unable to cooperate.

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Long QT Syndrome; Attention Deficit Disorder with Hyperactivity; Depression; Death; Death, Sudden, Cardiac; Romano-Ward Syndrome; Pathologic Processes; Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Arrhythmias, Cardiac; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Genetic Diseases, Inborn; Mental Disorders

Interventions

Echocardiography; Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cardiac Conduction System Disease; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD research fellow (Ph.D)

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 22, 2018
• Study Start: August 15, 2018
• Primary Completion: September 3, 2019
• Study Completion: January 1, 2022
• Last Updated: January 3, 2019

Record last verified: 2019-01

Locations

DK (1)