Fluoxetine is an effective and safe drug which has been successfully used for many years to relieve depression (also known as PROZAC manufactured by Eli Lilly). However, it may also improve brain function to enhance recovery from the physical effects of a stroke. A recent small French trial suggested that it might improve strength recovery in stroke survivors with residual arm weakness.
We wish to find out whether fluoxetine improves recovery if given to stroke survivors between 5 and 15 days after their stroke who still have residual problems such as a weak arm, weak leg or language problems. We also want to know if this drug helps overcome weakness, communication difficulties or fatigue, by performing a large UK trial, recruiting approximately 3000 patients. Half the patients will be given fluoxetine for 6 months and the other half will receive a placebo pill.
Before a large trial in stroke survivors can be conducted, an initial start-up phase is required to test the methodology. The current application to The Stroke Association is to fund the start-up phase, which will seek to recruit 200 patients and if successful will proceed into the main phase of the trial.