The selective serotonin reuptake inhibitor (SSRI) fluoxetine is commonly used in treating depression and emotional lability after stroke. Results from previous small trials have also suggested that fluoxetine may have a role in improving functional outcomes after stroke, although this potential effect has not been studied in a large controlled trial. In this randomized controlled trial, 3,127 patients with a clinical diagnosis of acute stroke were assigned to either 20 mg fluoxetine or placebo once daily for 6 months to study the impact on functional status as assessed by the modified Rankin Scale (mRS). Researchers found that functional status was similar between the two groups at 6 months (common OR 0.951, 95% CI 0.839 to 1.079, p=0.439). Patients in the fluoxetine group were less likely to be diagnosed with new depression at 6 months (13.43%) than those in the placebo group (17.21%) (difference 3.78%, 95% CI 1.26 to 6.30, p=0.0033). However, patients in the fluoxetine group were also at an increased risk of bone fracture at 6 months (2.88%) as compared to those in the placebo group (1.47%) (difference 1.41%, 95% CI 0.38 to 2.43, p=0.0070). The primary limitation of this trial was that there was only moderate adherence to the trial medication, which may have resulted in underestimation of the treatment effect. In summary, results from this trial do not support this use of fluoxetine for recovery of function after acute stroke.
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