Fluoxetine Or Control Under Supervision (FOCUS)

• Research type

  Research Study

• Full title

  A multicentre randomised trial to establish the effect(s) of routine administration of Fluoxetine for six months in patients with a recent stroke

• IRAS ID

  84669

• Contact name

  Gillian Mead

• Sponsor organisation

  University of Edinburgh

• Eudract number

  2011-005616-29

• Research summary

  A stroke is caused by sudden blockage or bursting of an artery in the brain. Stroke is the most common cause of adult disability in the UK. New treatments are needed to reduce the burden of disability caused by strokefluxetine is an effective and safe drug which has been successfully used for many years to relieve depression. Recent research has suggested that it also has other effects on the brain that may help patients make a better recovery from the physical effects of their stroke e.g. development of new brain cells (neurogenesis). For example, a recent small trial from France (the FLAME trial) suggested thafluxetine might improve the recovery of strength in stroke survivors with residual arm weakness. These promising results now need to be confirmed by a definitive trial recruiting a much larger number of patients. The overall aim of our research is to find out whethefluxetine improves recovery if given to stroke survivors who are between 2 and 15 days after the onset of their stroke, and who still have residual problems such as a weak arm, weak leg or language problems. We will also find out whether it helps the stroke survivor overcome weakness, communication difficulties or fatigue. We will do this by performing a large randomised trial in the UK, recruiting approximately 3000 patients. Half the patients will be randomly allocatefluxetine for 6 months, and the other half will receive a placebo pill. For patients who cannot swallow, we will give the drug or a matching placebo through their feeding tube. Patients will be followed up at 6 months, and then at 12 months, to see whether any benefits persist long-term.

• REC name

  Scotland A REC

• REC reference

  11/SS/0100

• Date of REC Opinion

  21 Dec 2011

• REC opinion

  Further Information Favourable Opinion