Escitalopram Treatment In Acute Stroke

NCT ID: NCT01561092

Last Updated: 2012-06-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Escitalopram

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: DRUG

5 or 10 mg escitalopram tablets administered orally once daily

Non active drug

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets

Interventions

Escitalopram

5 or 10 mg escitalopram tablets administered orally once daily

Intervention Type: DRUG

Placebo

Tablets

Intervention Type: DRUG

Other Intervention Names

SSRI; Cipralex

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grethe Andersen, Prof. DMSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Aarhus, Neurology Dept.

Locations

Neurology Department, Aalborg Hospital

Aalborg, , Denmark

Neurology Department, University Hospital of Aarhus

Aarhus, , Denmark

Neurology Department, Glostrup Hospital

Glostrup Municipality, , Denmark

Countries

Denmark

Other Identifiers

397-2011

Identifier Type: -

Identifier Source: org_study_id