Drug-induced Repolarization ECG Changes

Depression Clinical Trial

Official title:

Exploring the Effect of Methylphenidate and Antidepressants on Cardiac Repolarisation.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03642405
• Other study ID #: HerlevH01
• Status: Active, not recruiting
• Start date: August 15, 2018
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2019
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: January 1, 2022
• Est. primary completion date: September 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Electrocardiogram examination
12-lead ECG monitored by Holter
• 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

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.