Fluoxetine to improve functional outcomes in patients after acute stroke: the FOCUS RCT

Area of Science:

• Neuroscience
• Clinical Medicine
• Pharmacology

Background:

• Previous Cochrane reviews suggested selective serotonin reuptake inhibitors (SSRIs) might aid stroke recovery, but cited small trial sizes and high bias risk.
• The Fluoxetine Or Control Under Supervision (FOCUS) trial aimed to rigorously test fluoxetine's efficacy in post-stroke functional recovery.

Purpose of the Study:

• To evaluate the effectiveness of daily fluoxetine (20 mg) compared to placebo for improving functional recovery in patients following an acute stroke.

Main Methods:

• A pragmatic, multicenter, randomized, placebo-controlled trial involving 3127 adult patients within 2-15 days of stroke onset.
• Patients received either fluoxetine 20 mg daily or placebo for 6 months, with outcomes assessed at 6 and 12 months using the modified Rankin Scale.

Main Results:

• No significant difference in functional recovery (modified Rankin Scale at 6 months) between the fluoxetine and placebo groups (OR 0.951, p=0.439).
• Fluoxetine significantly reduced the incidence of depression (13.0% vs 16.9%, p=0.003) but increased bone fractures (2.9% vs 1.5%, p=0.007).
• No significant differences were observed in other adverse events, health-related quality of life, or healthcare costs.

Conclusions:

• Daily fluoxetine for 6 months post-stroke does not improve functional outcomes but may decrease depression and increase fracture risk.
• Findings inform clinical decisions regarding fluoxetine use for functional recovery versus mood disorder prevention/treatment in stroke survivors.
• Results from concurrent AFFINITY and EFFECTS trials will be combined in a meta-analysis for more precise effect estimates.