Drug-induced Repolarization ECG Changes

Exploring the Effect of Methylphenidate and Antidepressants on Cardiac Repolarisation.

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".

Study Overview

• Status: Unknown
• Conditions: Depression; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Death; Death, Sudden; Arrhythmias, Cardiac; ADHD; Heart Arrest; Heart Defects, Congenital; Cardiovascular Abnormalities; Genetic Disease; Death, Sudden, Cardiac; Psychiatric Disorder; Genetic Syndrome; Long QT Syndrome; Qt Interval, Variation in; Romano-Ward Syndrome; Electrocardiogram: Electrical Alternans
• Intervention / Treatment: Diagnostic test: Electrocardiogram examination; Diagnostic test: Echocardiography; Procedure: Blood Samples; Behavioral: Questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital at Herlev

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Anticipated): September 3, 2019
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): January 3, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Disease; Cardiac Conduction System Disease; Heart Diseases; Cardiovascular Diseases; Syndrome; Problem Behavior; Death; Mental Disorders; Congenital Abnormalities; Arrhythmias, Cardiac; Heart Arrest; Heart Defects, Congenital; Cardiovascular Abnormalities; Death, Sudden, Cardiac; Genetic Diseases, Inborn; Pathologic Processes; Death, Sudden; Long QT Syndrome; Romano-Ward Syndrome
• Other Study ID Numbers: HerlevH01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No