Anxiety, Depression
Conditions
Brief summary
The purpose of this study is to evaluate if the use of antidepressant medication in depressed patients with implantable cardioverter defibrillator reduces the number of ICD's shocks as it improves depressive affect.
Detailed description
episodes of arrhythmia remain present even after icd implantation, this is specially true in depressed patients. it is hypothesized that improving mood state by means of an antidepressant drug . namely mirtazapine. could be responsible of alleviating the number of appropriate shocks delivered by the cardioverter. this could be due to a direct effect of the drug itself or an indirect effect of improving anxious and depressive affect. the mood and anxiety state are measured with the HADS scale
Interventions
DRUGmirtazapine
mirtazapine 15 mg daily tablets
Sponsors
Universidad Nacional de Rosario
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 87 Years
Healthy volunteers
No
Inclusion criteria
* cardioverter implanted patients * depression * anxiety
Exclusion criteria
* heart failure * other diseases reducing physical fitness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of implantable cardioverter defibrillator shocks | one year |
Secondary
| Measure | Time frame |
|---|---|
| improvement of depression | one year |
Countries
Argentina
Outcome results
None listed