Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial

RCT (n=1500) found functional outcome (modified Rankin Scale) after acute stroke did not improve with fluoxetine 20 mg once daily for 6 months (OR 0·94; 95% CI 0·78-1·13;p=0·42), and though it reduced occurrence of depression, it increased risk of bone fractures and hyponatraemia

SPS commentary:

This is one of two almost identical phase 3 trials in The Lancet Neurology, examining the effects of fluoxetine on disability 6 months after stroke. The AFFINITY study (n=1280) also found fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome (modified Rankin Scale)vs placebo (OR 0·94, 95% CI 0·76–1·15; p=0·53), and increased the risk of falls, bone fractures, and epileptic seizures.


A commentary notes these two trials followed the larger Fluoxetine Or Control Under Supervision (FOCUS) trial conducted at 103 sites in the UK (n=3127) and all three trials convincingly show that the use of 20 mg oral fluoxetine prescribed daily and starting 2–15 days after stroke has no effects on the modified Rankin Scale (mRS) compared with placebo. It suggests that before closing the chapter on pharmacological enhancement of recovery after brain injury, it is worth revisiting why fluoxetine was considered a recovery drug in the first place. It adds that AFFINITY and EFFECTS started before FOCUS and it is now not clear what their added value is but in a world of finite resources, these trials illustrate the need for a global agenda for stroke recovery research that allows optimal alignment to address complementary research questions.


The Lancet Neurology

Resource links: