The main objective is to investigate whether and to what extent the QTc-time prolongs with the use of different types of antidepressants in adults treated with antidepressants for anxiety disorders. In addition we will investigate if there are…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the incidence of QTc-prolongation caused by
different types of antidepressants use, measured by the difference in QTc-time
between baseline and after six weeks of antidepressant use within one person.
Secondary outcome
We investigate whether there is a difference between the different types of
antidepressants (serotonin-reuptake inhibitors, serotonine-noradrenaline
reuptake inhibitors, tricyclic antidepressants, mono-amine oxidase inhibitors)
on the prolongation of the QTc-interval. In addition we will investigate if
there are specific risk factors that contribute to this prolongation.
Background summary
The QTc-interval is the time, corrected for the heart rhythm, which is
necessary for the heart muscle cells to repolarise. However, if this interval
increases too much and the cells do not repolarise simultaneously, there may
occur potentially fatal arrhythmias as Torsades de Pointes. Prolongation of the
QTc-interval may occur as a side effect of the use of antidepressants. However,
the exact incidence and clinical relevance of this side effect, especially in
younger people, is yet unknown.
Study objective
The main objective is to investigate whether and to what extent the QTc-time
prolongs with the use of different types of antidepressants in adults treated
with antidepressants for anxiety disorders. In addition we will investigate if
there are differences between the types of antidepressants and if there are
specific risk factors that contribute to this prolongation.
Study design
prospective cohort study.
Study burden and risks
Patients need to fill in a questionnaire and need to undergo at least two ECG
investigations. If deemed necessary (in case of QTc-prolongation) a blood
sample analysis will take place, this is care as usual. These interventions can
be stressful. Data that will be collected by this questionnaire are: DSM IV
diagnosis, type of antidepressant and dosage, sex, length, weight, age, medical
history (e.g. liver/renal disorders, heart suffering, diabetes), family history
(e.g. for acute heart death), medication use and substance abuse. A benefit for
the patients is that they undergo additional ECG checks (compared to treatment
according to the guidelines), providing the early detection of abnormalities.
If a prolonged QTc-interval of 500 ms or more is found, patients will be
referred to the cardiologist. There is a risk that a previously unknown
deviation is discovered at the ECG, which may affect the future of the patient.
Patients will be notified of these risks in advance.
Lijnbaan 4
Den Haag 2512 VA
NL
Lijnbaan 4
Den Haag 2512 VA
NL
Listed location countries
Age
Inclusion criteria
- Age between 18 and 55 years.
- Under treatment of the department of Anxiety Disorders, PsyQ, The Hague.
- Indication to start with antidepressant medication and not known to have a contra-indication to start with this kind of medication, e.g. severe liver dysfunction, long QT-syndrome, recent myocardial infarct.
- Able and willing to give informed consent.
Exclusion criteria
- Patients who had used already antidepressant medication in the 6 weeks prior to the inclusion.
- Patients who already use QT-prolonging anti-arrhythmic medication (e.g. sotalol, amiodarone).
- Patients who do not meet inclusion-criteria.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL45858.058.13 |