Escitalopram Treatment In Acute Stroke

Phase 4

Withdrawn

• Conditions: Stroke
• Interventions: Drug: Escitalopram; Drug: Placebo

• Registration Number: NCT01561092
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-22
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-18
• Last Update Posted: 2012-06-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Escitalopram	Escitalopram	-
Non active drug	Placebo	-

Primary Outcome Measures

Name	Time	Method
New vascular events	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Neurology Department, University Hospital of Aarhus; 🇩🇰 Aarhus, Denmark

Neurology Department, Glostrup Hospital; 🇩🇰 Glostrup, Denmark

Neurology Department, Aalborg Hospital; 🇩🇰 Aalborg, Denmark