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Drug-induced Repolarization ECG Changes

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ClinicalTrials.gov Identifier: NCT03642405
Recruitment Status : Active, not recruiting
First Posted : August 22, 2018
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Marstrand, Copenhagen University Hospital at Herlev

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".

Condition or disease Intervention/treatment
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 Diagnostic Test: Electrocardiogram examination Diagnostic Test: Echocardiography Procedure: Blood Samples Behavioral: Questionnaire

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploring the Effect of Methylphenidate and Antidepressants on Cardiac Repolarisation.
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : September 3, 2019
Estimated Study Completion Date : January 1, 2022


Group/Cohort Intervention/treatment
Methylphenidate-Group
The group is examined before and after intake of Methylphenidate
Diagnostic Test: Electrocardiogram examination
12-lead ECG monitored by Holter

Diagnostic Test: 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

Methylphenidate and know QT-prolonging SSRI
The group is examined before and after intake of Methylphenidate
Diagnostic Test: Electrocardiogram examination
12-lead ECG monitored by Holter

Diagnostic Test: 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

Methylphenidate and non-QT-prolonging SSRI
The group is examined before and after intake of Methylphenidate
Diagnostic Test: Electrocardiogram examination
12-lead ECG monitored by Holter

Diagnostic Test: 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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642405


Locations
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Denmark
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev

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Responsible Party: Peter Marstrand, MD research fellow (Ph.D), Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT03642405     History of Changes
Other Study ID Numbers: HerlevH01
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Arrhythmias, Cardiac
Long QT Syndrome
Heart Arrest
Heart Defects, Congenital
Death, Sudden, Cardiac
Cardiovascular Abnormalities
Romano-Ward Syndrome
Congenital Abnormalities
Genetic Diseases, Inborn
Syndrome
Death
Pathologic Processes
Death, Sudden
Mental Disorders
Problem Behavior
Cardiovascular Diseases
Disease
Behavioral Symptoms
Cardiac Conduction System Disease
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents