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Drug-induced Repolarization ECG Changes

Exploring the Effect of Methylphenidate and Antidepressants on Cardiac Repolarisation.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03642405
Enrollment
150
Registered
2018-08-22
Start date
2018-08-15
Completion date
2022-01-01
Last updated
2019-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTElectrocardiogram examination

12-lead ECG monitored by Holter

DIAGNOSTIC_TESTEchocardiography

Echocardiography in accordance to Danish Society of Cardiology

PROCEDUREBlood 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).

BEHAVIORALQuestionnaire

Questionnaire regarding patients quality of life

Sponsors

Copenhagen University Hospital at Herlev
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
ECG changesThrough 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026