title: TALOS: a multicenter, randomized, double-blind, placebo-controlled trial to test the effects of citalopram in patients with acute stroke.
abstract: BACKGROUND
  Selective Serotonin Reuptake Inhibitors (SSRI) are effective in the treatment of post-stroke depression and may have potential neuroprotective and vascular effects. Data from registry studies have further indicated a protective effect against recurrent ischemic events, but also an increased risk of bleeding in patients with ischemic stroke. Therefore, prospective studies are needed to determine the effects of SSRI treatment after acute ischemic stroke.
  
  
  OBJECTIVE
  TALOS is an investigator-initiated, national multicenter randomized- and placebo-controlled, double-blind trial testing citalopram in acute ischemic stroke. We hypothesize that citalopram treatment initiated in the acute phase after ischemic stroke will improve outcome assessed by the modified Rankin Score (mRS) and reduce the risk of death from vascular causes, transient ischemic attack (TIA)/stroke and myocardial infarction.
  
  
  RESULTS
  There are two co-primary effect variables: (i) Functional status at six-months, measured by the modified Rankin Scale, and (ii) Vascular death, TIA/stroke and myocardial infarction. Secondary effect variables include: (i) Single primary outcomes; (ii) The Barthel Index; (iii) Mini Mental State Examination at six-months; (iv) Final infarct size (Magnetic Resonance Imaging).
  
  
  CONCLUSIONS
  SSRI treatment is well tolerated and overall beneficial in the wake of stroke; it may also be neuroprotective and prevent new vascular events.
authors: Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.
authors: Kristian Lundsgaard
authors: KL
authors: Kraglund
authors: Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.
authors: Janne Kaergaard
authors: JK
authors: Mortensen
authors: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
authors: Erik Lerkevang
authors: http://orcid.org/0000-0002-1466-0865
authors: EL
authors: Grove
authors: Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
authors: Søren Paaske
authors: SP
authors: Johnsen
authors: Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.
authors: Grethe
authors: G
authors: Andersen
mesh_terms: D002545:Brain Ischemia / Q000188:drug therapy* / Q000503:physiopathology; D015283:Citalopram / Q000627:therapeutic use*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D008609:Mental Status Schedule; D009203:Myocardial Infarction / Q000503:physiopathology / Q000517:prevention & control; D018696:Neuroprotective Agents / Q000627:therapeutic use; D018579:Patient Selection; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D012720:Severity of Illness Index; D020521:Stroke / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome
chemical_list: D015283:Citalopram; D018696:Neuroprotective Agents; D017367:Selective Serotonin Reuptake Inhibitors
keywords: SSRI; acute ischemic stroke; clinical trials; neuroprotection; protocols; randomized-controlled trial