Clinical trial NCT01561092: Escitalopram Treatment In Acute Stroke
Official title: Efficacy of Escitalopram Treatment in Acute Stroke and the Role of SERT Genotype in Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Stroke
Keywords: Stroke
RCT
SSRI
Outcome
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2012-03-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: New vascular events
timeFrame: 6 months
Secondary outcomes:
measure: Death of any cause
timeFrame: 6 months
measure: Myocardial Infarction
timeFrame: 6 months
measure: Re-stroke
timeFrame: 6 months
measure: Motor function
timeFrame: 6 months
measure: White Matter lesions
timeFrame: 6 months
measure: Bleeding complications
timeFrame: 6 months
measure: Combined vascular death
timeFrame: 6 months
measure: Cognitive abilities
timeFrame: 6 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Neurology Department, Aalborg Hospital
city: Aarhus
country: Denmark
facility: Neurology Department, University Hospital of Aarhus
city: Glostrup
country: Denmark
facility: Neurology Department, Glostrup Hospital
Study officials:
affiliation: University Hospital of Aarhus, Neurology Dept.
name: Grethe Andersen, Prof. DMSc
role: PRINCIPAL_INVESTIGATOR
References: