The Efficacy of Citalopram Treatment in Acute Stroke

• Status: Completed
• Trial end date: 2016-12-19
• Target enrollment: 0
• Participant gender: All

Summary

We wish to conduct a prospective, randomized, double blind, placebo controlled multi center study of the combined neuroprotective and antithrombotic effects of SSRI treatment after stroke.

Hypotheses:

SSRI treatment commenced in the acute phase of stroke (day 0-7) protects against new thromboembolic events and leads to better rehabilitation. 600 stroke patients will be randomized in a 1:1 ratio.

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Danish Council for Independent Research; The Danish Regions Medicine Foundation
• Treatments: Citalopram; Dexetimide; Serotonin; Serotonin Uptake Inhibitors

Criteria

Inclusion Criteria:

• First ever ischemic stroke

• Age 18 years or above

Exclusion Criteria:

• Hemorrhagic stroke

• Dementia or other neurodegenerative disease

• Antidepressant medical 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 (eGFR below 30 ml/min per 1.73m2)

• Hyponatremia (S-potassium below 130 mmol/l)

• Actively bleeding ulcer

• Fatal stroke or other severe co-morbidity that markedly decreases expected life span

• Prolonged corrected QT-interval (QTc above 480 ms)

• Ongoing treatment with drugs known to prolong the QTc interval