6/28/23, 9:51 PM EFFECTS Pathway Feedback Search Clinical Topics Home Studies EFFECTS EFFECTS Disease Disease Acute ischemic stroke Intracerebral hemorrhage Trial question What is the role of fluoxetine in patients with acute stroke? Study design Multi-center Double blinded RCT Population Characteristics of study participants 38.0% female N = 1500 62.0% male 1500 patients (575 female, 925 male) Inclusion criteria: adult patients with a clinical diagnosis of ischemic or intracerebral hemorrhage in the previous 2-15 days Key exclusion criteria: primary subarachnoid hemorrhage; epileptic seizures; unavailable for follow-up for next 12 months; previous drug overdose or attempted suicide; ongoing depression Interventions N=750 fluoxetine (an oral dose of 20 mg/day for 6 months) N=750 placebo (matching placebo for 6 months) Primary outcome Physical function as measured by stroke impact scale score 77.4 77.4 76.7 58 1 https://web.pathway.md/studies/recI0fnac7i4Tt6vg 1/2 6/28/23, 9:51 PM EFFECTS Pathway 58.1 38.7 19.4 No significant difference 0.0 Fluoxetine Placebo No significant difference in physical function as measured by the stroke impact scale score (76.7 vs. 77.4; AD -0.7, 95% CI -6.06 to 4.66) Secondary outcomes Significant decrease in memory as measured by the stroke impact scale score (89.3 vs. 92.9; AD -3.6, 95% CI -6.19 to -1.01) Safety outcomes No significant differences in death, new stroke, thrombotic events, bleeding events. Significant differences in new depression (7% vs. 11%), bone fractures (4% vs. 2%), hyponatremia (1% vs. <1%) at 6 months. Conclusion In adult patients with a clinical diagnosis of ischemic or intracerebral hemorrhage in the previous 2-15 days, fluoxetine was not superior to placebo with respect to physical function as measured by the stroke impact scale score. Reference EFFECTS Trial Collaboration. Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2020 Aug;19(8):661-669. Open reference URL https://web.pathway.md/studies/recI0fnac7i4Tt6vg 2/2