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Clinical trial findings suggest common antidepressant does not aid stroke recovery

Dec 2018: The results of the FOCUS clinical trial have shown that stroke patients prescribed a common antidepressant show no improvement compared with those given a dummy drug.

CCBS researchers have published the findings of FOCUS - a clinical trial testing the effect of fluoxetine on improving physical ability in stroke patients.

In the trial, which involved more than 3000 stroke patients at over 100 hospitals around the UK, people were assigned to take fluoxetine or a placebo for six months. Fluoxetine is a common type of antidepressant that includes the branded drugs Prozac and Prozep.  Earlier research from France had suggested that taking the drug might reduce disability after stroke. 

Those who took fluoxetine were less likely to develop depression, but, there was a small increase in bone fractures reported in this group. Researchers say their findings do not support the use of fluoxetine to promote recovery after stroke in the UK.


FOCUS has shown that there is no benefit in the routine prescription of fluoxetine to improve recovery after a stroke, contrary to the promising results of smaller trials. There are other reasons a patient may be prescribed fluoxetine and we do not recommend that people change their treatment regimen without first consulting with their doctor.

Professor Gillian MeadCentre for Clinical Brain Sciences, co-Chief Investigator of the FOCUS trial

We have been working closely with researchers in Australia and Sweden who are running similar trials, the AFFINITY and EFFECTS trials. The results of those studies will reveal whether taking fluoxetine might offer benefits for stroke patients in other health systems.

Professor Martin DennisCentre for Clinical Brain Sciences, co-Chief Investigator of the FOCUS trial

The study  was funded by the Stroke Association and the National Institute for Health Research (NIHR). The findings are being announced at the UK Stroke Forum annual conference in Telford, UK.

Related links

Read the publication in The Lancet: Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. doi.org/10.1016/S0140-6736(18)32823-X

Brain vascular disease (including stroke) research at the Centre for Clinical Brain Sciences

Professor Gillian Mead's profile

Professor Martin Dennis' profile