Growing international scientific evidence has indicated a positive effect of SSRI treatment (serotonin reuptake inhibitors) after stroke, beyond its antidepressant effect. We wish to conduct a prospective randomised double blind placebo-controlled multicenter study of the combined neuroprotective and antithrombotic effects of SSRI treatment after stroke. Deletion of the SERT (serotonin transporter) gene may influence this treatment effect and may in itself be a risk factor for stroke, an aspect we also wish to explore.
1. SSRI treatment commenced in the acute phase of stroke (day 2-5) protects against new thromboembolic events and leads to better rehabilitation.
2. A specific SERT genotype is associated with an increased risk of first ever stroke.
3. A specific SERT genotype is associated with a higher risk of post stroke depression.
600 stroke patients will be randomised to either escitalopram or placebo treatment in a 1:1 ratio and genotyped according to SERT polymorphisms. The treatment and follow up period is 6 months. During these 6 months there will be 2 clinical follow up visits, one telephone control and one visit to evaluate compliance regarding medication. Patients who had an MRI as a part of the routine investigations done upon admission (approximately 300 patients) will have a control MRI after 6 months.
Additionally 400 patients, not eligible for participation i the randomised controlled trial, will be genotyped and answer questionnaires after 1 and 6 months.
Trial Stopped: Study medication could not be supplied. An alternative project will be conducted
- Escitalopram (Lexapro)Drug
Other Names: SSRI; Cipralex Intervention Desc: 5 or 10 mg escitalopram tablets administered orally once daily ARM 1: Kind: Experimental Label: Escitalopram
- Placebo Drug
Intervention Desc: Tablets ARM 1: Kind: Experimental Label: Non active drug
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||New vascular events||6 months||No|
|Secondary||Death of any cause||6 months||No|
|Secondary||Myocardial Infarction||6 months||No|
|Secondary||Motor and cognitive abilities||6 months||No|
|Secondary||White Matter lesions||6 months||No|
|Secondary||Bleeding complications||6 months||Yes|
|Secondary||Combined vascular death||6 months||No|
|Secondary||Motor function||6 months||No|
|Secondary||Cognitive abilities||6 months||No|