Drug-induced Repolarization ECG Changes

NCT ID: NCT03642405

Last Updated: 2019-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-15

Study Completion Date

2022-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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".

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Defects, Congenital 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 Cardiovascular Abnormalities Congenital Abnormalities Genetic Disease Genetic Syndrome Qt Interval, Variation in Psychiatric Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Methylphenidate-Group

The group is examined before and after intake of Methylphenidate

Electrocardiogram examination

Intervention Type DIAGNOSTIC_TEST

12-lead ECG monitored by Holter

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Echocardiography in accordance to Danish Society of Cardiology

Blood Samples

Intervention Type PROCEDURE

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

Intervention Type BEHAVIORAL

Questionnaire regarding patients quality of life

Methylphenidate and know QT-prolonging SSRI

The group is examined before and after intake of Methylphenidate

Electrocardiogram examination

Intervention Type DIAGNOSTIC_TEST

12-lead ECG monitored by Holter

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Echocardiography in accordance to Danish Society of Cardiology

Blood Samples

Intervention Type PROCEDURE

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

Intervention Type BEHAVIORAL

Questionnaire regarding patients quality of life

Methylphenidate and non-QT-prolonging SSRI

The group is examined before and after intake of Methylphenidate

Electrocardiogram examination

Intervention Type DIAGNOSTIC_TEST

12-lead ECG monitored by Holter

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Echocardiography in accordance to Danish Society of Cardiology

Blood Samples

Intervention Type PROCEDURE

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

Intervention Type BEHAVIORAL

Questionnaire regarding patients quality of life

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Electrocardiogram examination

12-lead ECG monitored by Holter

Intervention Type DIAGNOSTIC_TEST

Echocardiography

Echocardiography in accordance to Danish Society of Cardiology

Intervention Type DIAGNOSTIC_TEST

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).

Intervention Type PROCEDURE

Questionnaire

Questionnaire regarding patients quality of life

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peter Marstrand

MD research fellow (Ph.D)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Herlev Hospital

Herlev, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HerlevH01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.