Long QT SyndromeNCT03642405
Drug-induced Repolarization ECG Changes
An observational study of Long QT Syndrome and ADHD, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long QT Syndrome, ADHD, Depression
- What is being tested?
- Electrocardiogram examination, Echocardiography and Blood Samples
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2018to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Effect of Methylphenidate and Antidepressants on Cardiac Repolarisation.
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".
- Conditions
- Long QT Syndrome, ADHD, Depression, Death, Death, Sudden, Cardiac, Romano-Ward Syndrome
- Being tested
- Electrocardiogram examination, Echocardiography, Blood Samples, Questionnaire
- Medical subject headings
- Long QT Syndrome, Attention Deficit Disorder with Hyperactivity, Depression, Death, Death, Sudden, Cardiac, Romano-Ward Syndrome, Pathologic Processes, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocardiogram examinationDiagnostic test
12-lead ECG monitored by Holter
EchocardiographyDiagnostic test
Echocardiography in accordance to Danish Society of Cardiology
Blood SamplesProcedure or surgery
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).
QuestionnaireBehavioural
Questionnaire regarding patients quality of life
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate-Group | The group is examined before and after intake of Methylphenidate Receives: 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 Receives: 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 Receives: Diagnostic Test: Electrocardiogram examination; Diagnostic Test: Echocardiography; Procedure: Blood Samples; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG changes
The Primary Outcome assess whether there are changes on ECG, primary the QTc-interval, in participants receiving medication for ADHD and depression.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start15 Aug 2018
- Primary completion3 Sep 2019 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long QT SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Marstrand, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642405
- Sponsor's protocol ID
- HerlevH01
- Status last verified
- Jan 2019
- First submitted
- 16 Aug 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Methylphenidate and Antidepressants on Cardiac Repolarisation.
- ClinicalTrials.gov ID
- NCT03642405
- Acronym / sponsor ID
- HerlevH01
- Conditions
- Long QT Syndrome, ADHD, Depression, Death, Death, Sudden, Cardiac, Romano-Ward Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 3 Sep 2019 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate-Group | – | Diagnostic Test: Electrocardiogram examination, Diagnostic Test: Echocardiography, Procedure: Blood Samples, Behavioral: QuestionnaireThe group is examined before and after intake of Methylphenidate |
| Methylphenidate and know QT-prolonging SSRI | – | Diagnostic Test: Electrocardiogram examination, Diagnostic Test: Echocardiography, Procedure: Blood Samples, Behavioral: QuestionnaireThe group is examined before and after intake of Methylphenidate |
| Methylphenidate and non-QT-prolonging SSRI | – | Diagnostic Test: Electrocardiogram examination, Diagnostic Test: Echocardiography, Procedure: Blood Samples, Behavioral: QuestionnaireThe group is examined before and after intake of Methylphenidate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrocardiogram examination12-lead ECG monitored by Holter | Diagnostic test | Methylphenidate and know QT-prolonging SSRI, Methylphenidate and non-QT-prolonging SSRI, Methylphenidate-Group |
| EchocardiographyEchocardiography in accordance to Danish Society of Cardiology | Diagnostic test | Methylphenidate and know QT-prolonging SSRI, Methylphenidate and non-QT-prolonging SSRI, Methylphenidate-Group |
| Blood SamplesBlood 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). | Procedure or surgery | Methylphenidate and know QT-prolonging SSRI, Methylphenidate and non-QT-prolonging SSRI, Methylphenidate-Group |
| QuestionnaireQuestionnaire regarding patients quality of life | Behavioural | Methylphenidate and know QT-prolonging SSRI, Methylphenidate and non-QT-prolonging SSRI, Methylphenidate-Group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long QT Syndrome and ADHD, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG changes (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.