Drug-induced Repolarization ECG Changes

Study Overview
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Brief Summary
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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.

Official Title
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Exploring the Effect of Methylphenidate and Antidepressants on Cardiac Repolarisation.

Conditions
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Arrhythmias, Cardiac, 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, Heart Defects, Congenital, Cardiovascular Abnormalities, Congenital Abnormalities, Genetic Disease, Genetic Syndrome, Qt Interval, Variation in, Psychiatric Disorder

Intervention / Treatment
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* Diagnostic Test: Electrocardiogram examination
* Diagnostic Test: Echocardiography
* Procedure: Blood Samples
* Behavioral: Questionnaire


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Methylphenidate-Group<br>The group is examined before and after intake of Methylphenidate | Diagnostic Test: Electrocardiogram examination<br>* 12-lead ECG monitored by Holter<br>Diagnostic Test: Echocardiography<br>* Echocardiography in accordance to Danish Society of Cardiology<br>Procedure: Blood Samples<br>* 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).<br>Behavioral: Questionnaire<br>* Questionnaire regarding patients quality of life<br>|
| Methylphenidate and know QT-prolonging SSRI<br>The group is examined before and after intake of Methylphenidate | Diagnostic Test: Electrocardiogram examination<br>* 12-lead ECG monitored by Holter<br>Diagnostic Test: Echocardiography<br>* Echocardiography in accordance to Danish Society of Cardiology<br>Procedure: Blood Samples<br>* 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).<br>Behavioral: Questionnaire<br>* Questionnaire regarding patients quality of life<br>|
| Methylphenidate and non-QT-prolonging SSRI<br>The group is examined before and after intake of Methylphenidate | Diagnostic Test: Electrocardiogram examination<br>* 12-lead ECG monitored by Holter<br>Diagnostic Test: Echocardiography<br>* Echocardiography in accordance to Danish Society of Cardiology<br>Procedure: Blood Samples<br>* 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).<br>Behavioral: Questionnaire<br>* Questionnaire regarding patients quality of life<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |