Stroke MedDRA version: 14.1 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Cipralex
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Grethe Andersen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age over 18 years Clinically verified first ever ischemic stroke Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: Hemoragic stroke Dementia Antidepressant treatment within 30 days prior to inclusion Contraindications to SSRI treatment Liver/renal failure QTc prolongation (more than 500 ms)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objective is to examine whether escitalopram treatment in acute stroke improves physical and cognitive function.;Primary end point(s): Combined vascular mortality Myocardial infarction Re-stroke;Timepoint(s) of evaluation of this end point: 6 months after inclusion;Main Objective: The main objective is to examine whether escitalopram treatment in acute stroke reduces the risk of re-stroke and myocardial infarction | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mortality Vascular mortality Myocardial infarction Re-stroke Subclinical cerebral ischemic lesions Physical and cognitive skills Post stroke depression Pathological crying Fatique;Timepoint(s) of evaluation of this end point: 1 and 6 months | — |
Countries
Denmark
Contacts
Public ContactNeurology Department
Aarhus University Hospital
Outcome results
None listed