Escitalopram Treatment In Acute Stroke (ESTIAS)
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.
- SSRI treatment commenced in the acute phase of stroke (day 2-5) protects against new thromboembolic events and leads to better rehabilitation.
- A specific SERT genotype is associated with an increased risk of first ever stroke.
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of Escitalopram Treatment in Acute Stroke and the Role of SERT Genotype in Stroke|
- New vascular events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Death of any cause [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Myocardial Infarction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Re-stroke [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Motor function [ Time Frame: 6 months ] [ Designated as safety issue: No ]Fugl-Meyer Motor score is performed
- White Matter lesions [ Time Frame: 6 months ] [ Designated as safety issue: No ]Evaluated on MRI
- Bleeding complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Combined vascular death [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Cognitive abilities [ Time Frame: 6 months ] [ Designated as safety issue: No ]SDMT and MMSE tests are performed
|Active Comparator: Escitalopram||
5 or 10 mg escitalopram tablets administered orally once daily
|Placebo Comparator: Non active drug||
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561092
|Neurology Department, Aalborg Hospital|
|Aalborg, Denmark, 9000|
|Neurology Department, University Hospital of Aarhus|
|Aarhus, Denmark, 8000|
|Neurology Department, Glostrup Hospital|
|Glostrup, Denmark, 2600|
|Principal Investigator:||Grethe Andersen, Prof. DMSc||University Hospital of Aarhus, Neurology Dept.|