Escitalopram Treatment In Acute Stroke "ESTIAS"

Withdrawn

Phase 4 Results N/A

Trial Description

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:
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

Conditions

Interventions

  • Escitalopram (Lexapro)Drug
    Other Names: Lexapro
    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

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

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 Re-stroke 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

Sponsors