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Fluoxetine showed no benefit in functional recovery from stroke

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Review of: FOCUS Trial Collaboration. Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. Lancet 2019;393:265–74.

Key learning points

  • A large randomised trial of fluoxetine taken after a stroke found no statistically significant difference in functional status compared with placebo.

  • Fluoxetine resulted in a reduced rate of depression 6 months after stroke compared with placebo, but this effect was not sustained at 12 months.

  • Treatment with fluoxetine was associated with an increased risk of bone fractures at 6 months compared with placebo.

Fluoxetine did not improve functional status after acute stroke or cerebral ischaemia and was associated with a small increase in the risk of fractures.1


The Fluoxetine Or Control Under Supervision (FOCUS) trial was a large UK-based pragmatic multicentre parallel group double-blind randomised placebo-controlled trial that recruited …

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  • Contributors DTB Team.

  • Provenance and peer review Commissioned; internally peer reviewed.