An observational study in Long QT Syndrome, ADHD and Depression, sponsored by Copenhagen University Hospital at Herlev. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-03.
Sponsored by Copenhagen University Hospital at Herlev · Observational
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".
101 studies on the registry are indexed under Long QT Syndrome; 20 are open to participants now.
This study's planned enrollment of 150 is close to the median of 150 across 53 observational studies indexed under Long QT Syndrome.
Browse Long QT Syndrome studies →Copenhagen University Hospital at Herlev is the lead sponsor of 77 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The group is examined before and after intake of Methylphenidate
Diagnostic Test: Electrocardiogram examination · Diagnostic Test: Echocardiography · Procedure: Blood Samples · Behavioral: Questionnaire
The group is examined before and after intake of Methylphenidate
Diagnostic Test: Electrocardiogram examination · Diagnostic Test: Echocardiography · Procedure: Blood Samples · Behavioral: Questionnaire
The group is examined before and after intake of Methylphenidate
Diagnostic Test: Electrocardiogram examination · Diagnostic Test: Echocardiography · Procedure: Blood Samples · Behavioral: Questionnaire
12-lead ECG monitored by Holter
Echocardiography in accordance to Danish Society of Cardiology
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).
Questionnaire regarding patients quality of life
ECG changes
The Primary Outcome assess whether there are changes on ECG, primary the QTc-interval, in participants receiving medication for ADHD and depression.
Time frame: Through study completion, an average of 1 year.
Started Aug 2018 (actual). Primary completion is estimated for Sep 2019, 12 months after the start.
Of 21 observational studies under Long QT Syndrome, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 81. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Copenhagen University Hospital at Herlev