Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): A pragmatic, double-blind, randomised, controlled trial

The Lancet Jan 12, 2019

In this FOCUS trial collaboration, researchers assessed the effects fluoxetine on functional outcomes after stroke. Overall, they did not observe any benefits of providing fluoxetine 20 mg daily for 6 months after acute stroke in terms of functional outcomes. The treatment reduced the occurrence of depression but increased the frequency of bone fractures. Thus, the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function was not supported.


  • This multicenter, parallel group, double-blind, randomized, placebo-controlled trial was conducted at 103 UK hospitals.
  • Study participants included adults with a clinical stroke diagnosis who were randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits.
  • Participants received either fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimization algorithm.
  • Functional status, measured with the modified Rankin Scale (mRS), at 6 months was assessed as the primary outcome.
  • Treatment allocation was not revealed to patients, care givers, healthcare staff, or the trial team.
  • Assessment of functional status was done at 6 months and 12 months after randomization.
  • As per the treatment allocation, analysis of the patients was done.


  • A total of 3,127 patients were recruited between September 10, 2012, and March 31, 2017.
  • Researchers allocated 1,564 patients to receive fluoxetine and 1,563 to receive placebo.
  • In each treatment group, 1,553 (99.3%) patients had mRS data available at 6 months.
  • The fluoxetine and placebo groups had similar distribution across mRS categories at 6 months.
  • Patients who received fluoxetine displayed less tendency for developing new depression by 6 months vs those who received placebo; however, these patients had more bone fractures.
  • No significant differences in any other event at 6 or 12 months was noted.
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