Escitalopram Treatment In Acute Stroke

Stroke Clinical Trial

— ESTIAS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01561092
• Other study ID #: 397-2011
• Status: Withdrawn
• Phase: Phase 4
• First received: March 20, 2012
• Last updated: June 18, 2012

Study information

• Verified date: June 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Escitalopram
5 or 10 mg escitalopram tablets administered orally once daily
• Placebo
Tablets

Locations

Country	Name	City	State
Denmark	Neurology Department, Aalborg Hospital	Aalborg
Denmark	Neurology Department, University Hospital of Aarhus	Aarhus
Denmark	Neurology Department, Glostrup Hospital	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	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 function	Fugl-Meyer Motor score is performed	6 months	No
Secondary	White Matter lesions	Evaluated on MRI	6 months	No
Secondary	Bleeding complications		6 months	Yes
Secondary	Combined vascular death		6 months	No
Secondary	Cognitive abilities	SDMT and MMSE tests are performed	6 months	No