6/28/23, 10:37 PM FLAME (fluoxetine) Pathway Feedback Search Clinical Topics Home Studies FLAME (fluoxetine) FLAME (fluoxetine) Disease Acute ischemic stroke Trial question What is the effect of fluoxetine in patients who have motor deficits secondary to ischemic stroke? Study design Multi-center Double blinded RCT Population Characteristics of study participants 39.0% female N = 118 61.0% male 118 patients (46 female, 72 male) Inclusion criteria: patients aged between 18-85 years with ischemic stroke and hemiplegia or hemiparesis, who had Fugl-Meyer Motor Scale scores < 55 Key exclusion criteria: severe post-stroke disability, substantial premorbid disability, clinically diagnosed with depression, receipt of antidepressants, residual motor deficit from a previous stroke, severe aphasia Interventions N=59 fluoxetine (20 mg once per day PO for 3 months starting 5-10 days after the onset of stroke) N=59 placebo (matching placebo for 3 months starting 5-10 days after the onset of stroke) Primary outcome Change in Fugl-Meyer Motor Scale scores at day 90 34.0 points 34 https://web.pathway.md/studies/recaADdxEUULKch93 1/2 6/28/23, 10:37 PM FLAME (fluoxetine) Pathway 25.5 points 24.3 17.0 points 8.5 points Significant increase 0.0 points Fluoxetine Placebo Significant increase in change in Fugl-Meyer Motor Scale scores at day 90 (34 points vs. 24.3 points; AD 9.8 points, 95% CI 3.4 to 16.1) Secondary outcomes Significant increase in mRS score of 0-2 at day 90 (26% vs. 9%; AD 17%, 95% CI 3.29 to 30.71) Significant increase in change in Montgomery Asberg Depression Rating Scale score at day 90 (-0.1 vs. 3.2; AD 3.3, 95% CI 0.28 to 6.32) Safety outcomes No significant differences in adverse events, including hyponatremia, insomnia, psychiatric disorders, and partial seizure. Significant difference in transient digestive disorders (25% vs. 11%) and hepatic enzyme disorders (9% vs. 18%). Conclusion In patients aged between 18-85 years with ischemic stroke and hemiplegia or hemiparesis, who had Fugl-Meyer Motor Scale scores < 55, fluoxetine was superior to placebo with respect to change in Fugl-Meyer Motor Scale scores at day 90. Reference Chollet F, Tardy J, Albucher JF et al. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. Open reference URL https://web.pathway.md/studies/recaADdxEUULKch93 2/2