CClinicalTrials.gg
Status unknownNCT03642405Updated Jan 3, 2019

Drug-induced Repolarization ECG Changes

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

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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".

02

Conditions studied

  • Long QT Syndrome
  • ADHD
  • Depression
  • Death
  • Death, Sudden, Cardiac
  • Romano-Ward Syndrome
  • Pathologic Processes
  • Heart Arrest
  • Electrocardiogram: Electrical Alternans
  • Heart Diseases
  • Cardiovascular Diseases
  • Death, Sudden
  • Arrhythmias, Cardiac
  • Heart Defects, Congenital
  • Cardiovascular Abnormalities
  • Congenital Abnormalities
  • Genetic Disease
  • Genetic Syndrome
  • Qt Interval, Variation in
  • Psychiatric Disorder
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Methylphenidate-Group

    The group is examined before and after intake of Methylphenidate

    Diagnostic Test: Electrocardiogram examination · Diagnostic Test: Echocardiography · Procedure: Blood Samples · Behavioral: Questionnaire

  • Methylphenidate and know QT-prolonging SSRI

    The group is examined before and after intake of Methylphenidate

    Diagnostic Test: Electrocardiogram examination · Diagnostic Test: Echocardiography · Procedure: Blood Samples · Behavioral: Questionnaire

  • Methylphenidate and non-QT-prolonging SSRI

    The group is examined before and after intake of Methylphenidate

    Diagnostic Test: Electrocardiogram examination · Diagnostic Test: Echocardiography · Procedure: Blood Samples · Behavioral: Questionnaire

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

05

What researchers measure

Primary outcomes

  1. 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.

06

Study locations

1 site
  • Herlev Hospital
    Herlev, 2730, Denmark
07

Registry details

Key details

Study ID
NCT03642405
Lead sponsor
Copenhagen University Hospital at Herlev
Responsible party
Peter Marstrand (MD research fellow (Ph.D), Copenhagen University Hospital at Herlev) — Principal investigator
First posted
Aug 22, 2018
Start date
Aug 15, 2018
Primary completion
Sep 3, 2019 (estimated)
Completion
Jan 1, 2022 (estimated)
Last update
Jan 3, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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