Escitalopram Treatment In Acute Stroke
Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke
Intervention: Escitalopram (Drug); Placebo (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s): Grethe Andersen, Prof. DMSc, Principal Investigator, Affiliation: University Hospital of Aarhus, Neurology Dept.
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.
Clinical Details
Official title: Efficacy of Escitalopram Treatment in Acute Stroke and the Role of SERT Genotype in Stroke
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: New vascular events
Secondary outcome: Death of any causeMyocardial Infarction Re-stroke Motor function White Matter lesions Bleeding complications Combined vascular death Cognitive abilities
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Neurology Department, Aalborg Hospital, Aalborg 9000, Denmark
Neurology Department, University Hospital of Aarhus, Aarhus 8000, Denmark
Neurology Department, Glostrup Hospital, Glostrup 2600, Denmark
Additional Information
Last updated: June 18, 2012
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