Exploring the Effect of Methylphenidate and Antidepressants on Cardiac Repolarisation.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- ECG changes
Study Overview
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".
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
ECG changes
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Peter Marstrand
MD research fellow (Ph.D)
Copenhagen University Hospital at Herlev