Escitalopram Treatment In Acute Stroke

Study Overview
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Brief Summary
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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. Hypotheses: 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.

Official Title
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Efficacy of Escitalopram Treatment in Acute Stroke and the Role of SERT Genotype in Stroke

Conditions
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Stroke

Intervention / Treatment
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* Drug: Escitalopram
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First ever ischemic stroke Age 18 years or above Exclusion Criteria Hemorrhagic stroke Dementia or other neurodegenerative disease Antidepressant treatment within 6 months of admission Acute need for antidepressant treatment Drug abuse or other conditions that may indicate noncompliant behavior Liver failure (increased liver enzyme levels up to or more than 2 times upper limit) Renal failure (GFR under 30) Hyponatremia (S-potassium below 130 mmol/l) Actively bleeding ulcer Fatal stroke or other severe co morbidity that markedly decreases expected life span Prolonged QT interval (QTc above 500 ms) Ongoing treatment with drugs known to prolong the QT interval

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Escitalopram<br> | Drug: Escitalopram<br>* 5 or 10 mg escitalopram tablets administered orally once daily<br>* Other names: Cipralex;|
| Placebo Comparator: Non active drug<br> | Drug: Placebo<br>* Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New vascular events |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death of any cause |  | 6 months | 
| Myocardial Infarction |  | 6 months | 
| Re-stroke |  | 6 months | 
| Motor function | Fugl-Meyer Motor score is performed | 6 months | 
| White Matter lesions | Evaluated on MRI | 6 months | 
| Bleeding complications |  | 6 months | 
| Combined vascular death |  | 6 months | 
| Cognitive abilities | SDMT and MMSE tests are performed | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, RCT, SSRI, Outcome