Clinical Trial Results Indicate that Common Antidepressant Does Not Aid Stroke Recovery

A new University of Edinburgh-led study involved more than 3000 stroke patients at over 100 hospitals around the UK has found that stroke patients prescribed a common antidepressant show no improvement compared with those given a placebo (inactive substitute) drug. 

Earlier research from France had suggested that taking the drug, called fluoxetine, a common type of  antidepressant that includes the branded drugs Prozac and Prozep, might reduce disability after stroke.  However, this latest study called FOCUS, found no difference between the improvement in physical ability of stroke patients who took fluoxetine for six months and those who took a placebo. In this study, half of the participants started taking fluoxetine daily within the first two weeks of their stroke, while the remainder took a placebo. 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.

Experts stress that people already taking the drug should not stop without speaking to their doctor first.

Co-chief investigator Professor Gillian Mead, of the University of Edinburgh’s Centre for Clinical Brain Sciences, said: “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.”

Fellow co-chief investigator Professor Martin Dennis, of the University of Edinburgh’s Centre for Clinical Brain Sciences, said: “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.” 

The study was published in The Lancet and funded by the Stroke Association and the National Institute for Health Research (NIHR)

Original article in The Lancet