6/28/23, 12:04 AM AFFINITY Pathway Feedback Search Clinical Topics Home Studies AFFINITY AFFINITY Disease Disease Disease Acute ischemic stroke Intracerebral hemorrhage Subarachn Trial question What is the role of fluoxetine in patients after acute stroke? Study design Multi-center Double blinded RCT Population Characteristics of study participants 37.0% female N = 1280 63.0% male 1280 patients (476 female, 804 male) Inclusion criteria: adult patients with acute stroke, brain imaging consistent with ischemic or hemorrhagic stroke, and a persisting neurological deficit Key exclusion criteria: indication or contraindication for fluoxetine; life-threatening disease with < 12-month survival; pregnancy Interventions N=642 fluoxetine (an oral dose of 20 mg/day for 6 months) N=638 placebo (matching placebo daily for 6 months) Primary outcome New depression at 6 months https://web.pathway.md/studies/recFrG75xQDRwanEw 1/2 6/28/23, 12:04 AM AFFINITY Pathway 7.0 % 7 5.3 % 5 3.5 % 1.8 % No significant difference 0.0 % Fluoxetine Placebo No significant difference in new depression at 6 months (5% vs. 7%; ARD -2, 95% CI -4.59 to 0.59) Secondary outcomes No significant difference in health-related quality of life as measured by the European Quality of Life 5-dimensional 5-level questionnaire (0.81 vs. 0.78; AD 0.03, 95% CI 0 to 0.06) Safety outcomes No significant differences in death, recurrent stroke, thrombotic events, hemorrhagic stroke. Significant differences in epileptic seizures (2% vs. <1%), fall with injury (3% vs. 1%), and new bone fracture (3% vs. 1%) at 6 months. Conclusion In adult patients with acute stroke, brain imaging consistent with ischemic or hemorrhagic stroke, and a persisting neurological deficit, fluoxetine was not superior to placebo with respect to new depression at 6 months. Reference AFFINITY Trial Collaboration. Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2020 Aug;19(8):651-660. Open reference URL https://web.pathway.md/studies/recFrG75xQDRwanEw 2/2