Drug-induced Repolarization ECG Changes

Copenhagen University Hospital at Herlev

Status: Unknown

Conditions: Heart Defects, Congenital; Death; Heart Arrest; Arrhythmias, Cardiac; Genetic Syndrome; Congenital Abnormalities; Cardiovascular Diseases; ADHD; Pathologic Processes; Romano-Ward Syndrome; Death, Sudden, Cardiac; Psychiatric Disorder; Cardiovascular Abnormalities; Qt Interval, Variation in; Death, Sudden; Genetic Disease; Electrocardiogram: Electrical Alternans; Long QT Syndrome; Depression; Heart Diseases

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

Study type: Observational

Funder types: Other

Identifiers

NCT03642405

HerlevH01

Details and patient eligibility

About

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".

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

150 participants in 3 patient groups

Methylphenidate-Group

Description:

The group is examined before and after intake of Methylphenidate

Treatment:

Diagnostic Test: Echocardiography

Behavioral: Questionnaire

Diagnostic Test: Electrocardiogram examination

Procedure: Blood Samples

Methylphenidate and know QT-prolonging SSRI

Description:

The group is examined before and after intake of Methylphenidate

Treatment:

Diagnostic Test: Echocardiography

Behavioral: Questionnaire

Diagnostic Test: Electrocardiogram examination

Procedure: Blood Samples

Methylphenidate and non-QT-prolonging SSRI

Description:

The group is examined before and after intake of Methylphenidate

Treatment:

Diagnostic Test: Echocardiography

Behavioral: Questionnaire

Diagnostic Test: Electrocardiogram examination

Procedure: Blood Samples