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Funding: Public French National Programme for Clinical Research. This prescription trial is fluoxetine registered with ClinicalTrials. Participants, carers, and non physicians assessing the non outcome were non masked prescription to non group assignment. We therefore aimed to investigate whether fluoxetine would enhance motor fluoxetine recovery if given soon after an ischaemic stroke prescription to patients who have motor deficits. Fmms improvement at day 90 was significantly greater in non the fluoxetine group (adjusted mean 340 points 95 CI 297-384) than in fluoxetine the placebo fluoxetine 20mg group (243 points 199-287; p0003). The primary outcome measure was the change on the fmms between day 0 and day 90 after the start of fluoxetine the study drug. Copyright 2011 Elsevier Ltd. Patients were randomly assigned, using a overnight fluoxetine united healthcare fluoxetine computer random-number generator, in a 1:1 ratio to fluoxetine (20 mg once per day, orally) or overnight fluoxetine prescription placebo for 3 months starting 5-10 days prescription after the onset of stroke. A non few small clinical trials suggest that fluoxetine enhances motor recovery but its clinical efficacy is unknown. Analysis was of all patients for whom data were available (full analysis set). Modulation of spontaneous brain plasticity by drugs is a promising pathway for treatment prescription of patients with ischaemic stroke and moderate to severe motor deficit. The main adverse events in the fluoxetine and placebo groups were hyponatraemia (two 4 vs two 4 transient digestive disorders including nausea, diarrhoea, and abdominal pain (14 25 vs six 11 hepatic enzyme disorders (five 9 vs ten. Methods: In this double-blind, placebo-controlled trial, patients from nine stroke centres in France who had ischaemic stroke and hemiplegia or hemiparesis, had Fugl-Meyer motor scale (fmms) scores of 55 or less, and were aged between 18 years and 85 years were eligible for inclusion. Two patients died before day 90 and three withdrew from the study. Background: Hemiplegia and hemiparesis are the most prescription common deficits caused by stroke. Interpretation: In patients with ischaemic stroke and moderate to severe motor deficit, the early prescription prescription of fluoxetine with physiotherapy enhanced motor recovery after 3 months. Findings: 118 patients were randomly assigned to fluoxetine (n59) or placebo (n59 and 113 were included in the analysis (57 in the fluoxetine group and 56 in the placebo group). All patients had physiotherapy. 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