FOCUS: a new stroke clinical trial

£2M funding has been obtained for FOCUS: a multicentre randomised trial to establish the effect of Fluoxetine (Prozac) in stroke.

Stroke is the major cause of adult disability in the UK, and new treatments are needed to reduce the long-term physical and emotional problems faced by stroke survivors.

Selective serotonin reuptake inhibitors (SSRI) are a class of drug that have been used to treat mood disorders for many years. Several small trials have suggested that they might also promote brain recovery when given routinely early after stroke, even in patients without mood disorders.

The FOCUS trial (Fluoxetine or Control under Supervision), which is led by Professor Gillian Mead and Professor Martin Dennis of CCBS, aims to find out whether fluoxetine, a type of SSRI, started at 2 to 15 days after stroke, and continued for 6 months, improves recovery at 6 months, and whether any benefits persist to 12 months.

The start-up phase of FOCUS, funded by the Stroke Association, has demonstrated that a UK multicentre trial is feasible. The FOCUS investigators (G Mead, M Dennis, A House, J Forbes, M MacLeod, S Lewis, G Hankey, M Hackett, C Anderson, D Morales, F Sullivan) have now been awarded £2,088,149 from NIHR Health Technology Assessment over 4.5 years, for the main phase of the trial. This will recruit from up to 120 UK centres and complete recruitment of at least 3000 patients.

If Fluoxetine is effective, this simple treatment would be widely applicable throughout the world.

Parallel trials based on the design of FOCUS are being run in Sweden (EFFECTS) led by Erik Lundstrom and Veronica Murray; and Australia (AFFINITY) led by Graeme Hankey and Maree Hackett. The three teams are collaborating closely: for example, the Data Monitoring Committees of the three trials will share safety data, and when each trial has published its results, the data will be pooled.