FLUORESCE: A pilot randomized clinical trial of fluoxetine for vision recovery after acute ischemic stroke

Background and purpose: Post-stroke homonymous hemianopia is disabling and complete spontaneous recovery is rare. In this randomized, double-blind, placebo-controlled pilot clinical trial, we tested whether fluoxetine enhances vision recovery after stroke.

Methods: We randomized 17 consecutive adults 1:1 to 90 days of fluoxetine 20 mg daily vs. placebo within 10 days of an ischemic stroke causing homonymous hemianopia. The primary endpoint was percent improvement in 24-2 Humphrey perimetry at six months. Twelve participants completed the study.

Results: Intention-to-treat analysis of the primary endpoint, percent improvement in perimetric mean deviation, showed a non-significant benefit of fluoxetine (64.4%, n=5) over placebo (26.0%, n=7, 95% confidence interval (CI)=(-2.13,∞), p=0.06). The original blind field completely recovered in 60% receiving fluoxetine and 14% receiving placebo (odds ratio=7.22, 95%CI=(0.50,∞)).

Conclusions: These results suggest a trend in favor of fluoxetine and should be followed up with a multi-center trial.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02737930