Muhammad Rizwan Husain, MD
Lundström E, Isaksson E, Greilert Norin N, Näsman P, Wester P, Mårtensson B, Norrving B, Wallén H, Borg J, Hankey GJ, et al. Effects of Fluoxetine on Outcomes at 12 Months After Acute Stroke: Results From EFFECTS, a Randomized Controlled Trial. Stroke. 2021.
The Efficacy oF Fluoxetine—a randomisEd Controlled Trial in Stroke (EFFECTS) was a randomized clinical trial whose primary outcome was to assess if oral fluoxetine initiated within 2-15 days of an acute stroke (ischemic or hemorrhagic) and taken up to 6 months improved functional outcomes. The initial trial results, which were published in August 2020, demonstrated no improvement in functional outcomes (modified Rankin Score-mRS-adjusted odds ratio: 0.94 [95% CI 0.78–1.13]) at 6 months with fluoxetine use and noted an increased rate of fractures and hyponatremia, though occurrence of depression was reduced (by 4%).
The authors now report 12-month follow-up results on outcomes that include the mRS, health status, quality of life, fatigue, mood and depression to see if any effects of fluoxetine persisted or were delayed.