Drug-induced Repolarization ECG Changes

• Conditions: Heart Arrest; Cardiovascular Abnormalities; Psychiatric Disorder; Death, Sudden, Cardiac; Death, Sudden; Heart Defects, Congenital; Genetic Disease; Long QT Syndrome; ADHD; Depression
• Interventions: Diagnostic Test: Electrocardiogram examination; Diagnostic Test: Echocardiography; Procedure: Blood Samples; Behavioral: Questionnaire

• Registration Number: NCT03642405
• Lead Sponsor: Copenhagen University Hospital at Herlev

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".

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-15
• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-22
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-03
• Primary Completion: 2019-09-03
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Methylphenidate-Group	Electrocardiogram examination	The group is examined before and after intake of Methylphenidate
Methylphenidate and know QT-prolonging SSRI	Electrocardiogram examination	The group is examined before and after intake of Methylphenidate
Methylphenidate and know QT-prolonging SSRI	Echocardiography	The group is examined before and after intake of Methylphenidate
Methylphenidate and know QT-prolonging SSRI	Questionnaire	The group is examined before and after intake of Methylphenidate
Methylphenidate-Group	Echocardiography	The group is examined before and after intake of Methylphenidate
Methylphenidate-Group	Questionnaire	The group is examined before and after intake of Methylphenidate
Methylphenidate and know QT-prolonging SSRI	Blood Samples	The group is examined before and after intake of Methylphenidate
Methylphenidate-Group	Blood Samples	The group is examined before and after intake of Methylphenidate
Methylphenidate and non-QT-prolonging SSRI	Electrocardiogram examination	The group is examined before and after intake of Methylphenidate
Methylphenidate and non-QT-prolonging SSRI	Blood Samples	The group is examined before and after intake of Methylphenidate
Methylphenidate and non-QT-prolonging SSRI	Echocardiography	The group is examined before and after intake of Methylphenidate
Methylphenidate and non-QT-prolonging SSRI	Questionnaire	The group is examined before and after intake of Methylphenidate

Primary Outcome Measures

Name	Time	Method
ECG changes	Through study completion, an average of 1 year.	The Primary Outcome assess whether there are changes on ECG, primary the QTc-interval, in participants receiving medication for ADHD and depression.

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark