From the Department of Neurology, Acute Stroke Unit, Aarhus University Hospital, Denmark (K.L.K., J.K.M., A.G.D., G.A.)Department of Clinical Epidemiology, Aarhus University Hospital, Denmark (M.M., S.P.J.)Department of Cardiology, Aarhus University Hospital, Denmark (E.L.G.)Department of Neurology, Acute Stroke Unit, Aalborg University Hospital, Denmark (B.M.)Department of Neurology, Acute Stroke Unit, Rigshospitalet, University of Copenhagen, Denmark (S.A.S., H.K.I.)Faculty of Health, Institute of Clinical Medicine, Aarhus University, Denmark (E.L.G., S.P.J., G.A.).
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Background and Purpose—Recent studies indicate a possible beneficial effect on neuroregeneration and vascular protection of selective serotonin reuptake inhibitors after stroke. We conducted a national multicentre study to explore these effects.Methods—The TALOS study (The Efficacy of Citalopram Treatment in Acute Stroke) is a Danish placebo-controlled, randomized, double-blind study of citalopram started within 7 days after symptom onset to detect improvement in functional outcomes and cardiovascular protection in nondepressed, first-ever ischemic stroke. Study medication was given as add-on to standard medical care and treatment duration and follow-up was 6 months. There were 2 coprimary outcomes: changes in functional disability from 1 to 6 months on the modified Rankin Scale, and a composite vascular end point of transient ischemic attack/stroke, myocardial infarction, or vascular mortality during the first 6 months.Results—We enrolled 642 patients randomized to either citalopram (n=319) or placebo (n=323). Median National Institutes of Health Stroke Scale was 5.3 (range, 0–27) versus 4.8 (range, 0–28) at admission. Improvement in functional recovery from 1 to 6 months occurred in 160 (50%) patients on citalopram and 136 (42%) on placebo (odds ratio, 1.27; 95% CI, 0.92–1.74; P=0.057). When dropouts before 31 days were excluded (n=90), the analysis population showed an odds ratio of 1.37 (95% CI, 0.97–1.91; P=0.07). During a median follow-up of 150 days, 23 (7%) patients in the citalopram group and 26 (8%) patients in the placebo group had a primary, vascular end point (hazard ratio, 0.89; 95% CI, 0.50–1.60; P=0.24). A total of 28 patients (4%) died (16 versus 12; P=0.42) during the study.Conclusions—Early citalopram treatment did not improve functional recovery in nondepressed ischemic stroke patients within the first 6 months, although a borderline statistical significant effect was observed in the analysis population. The risk of cardiovascular events was similar between treatment groups, and citalopram treatment was well tolerated.Clinical Trial Registration—URL: https://www.clinicaltrials.gov. Unique identifier: NCT01937182. URL: https://www.clinicaltrialsregister.eu/. EudraCT number: 2013-002253-30.