Fluoxetine misses the mark as poststroke therapy

  • Lancet

  • curated by Susan London
  • Clinical Essentials
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.


  • 6 months of therapy with fluoxetine (Prozac, others) initiated soon after stroke did not improve functional outcome, and had potential harms.

Why this matters

Key results

  • Fluoxetine, placebo groups did not differ on 6-month distribution across modified Rankin Scale scores (adjusted common OR, 0.951; P=.439).
  • Findings were similar at 12 months and when score dichotomized 0-2 vs 3-6.
  • No significant differences on Stroke Impact Scale measures, vitality, QoL.
  • At 6 months, fluoxetine group vs placebo group:
    • lower depression incidence (13.43% vs 17.21%; P=.0033),
    • higher fracture incidence (2.88% vs 1.47%; P=.0070),
    • trend toward higher epileptic seizure incidence (3.71% vs 2.56%; P=.0651), and
    • trend toward higher fall with injury incidence (7.67% vs 6.01%; P=.0663).

Expert comment

  • In a Comment, H. Bart van der Worp, MD, PhD, writes, "Hopefully, results of the ongoing large randomised trials of fluoxetine in stroke, AFFINITY and EFFECTS, and the planned pooled analysis of the three trials will provide more insight into the effects of fluoxetine in specific patient populations and with specific background therapies."

Study design

  • UK multicenter randomized controlled FOCUS trial: 3127 adults with stroke onset 2-15 days earlier, and focal neurologic deficits.
  • Randomization: double-blind fluoxetine 20 mg or placebo daily for 6 months.
  • Main outcome: functional status (modified Rankin Scale).
  • Funding: UK Stroke Association; NIHR Health Technology Assessment Programme.


  • Only moderate adherence to trial medication.
  • Use of simplified modified Rankin Scale.

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.