Effects of Fluoxetine on Cognitive Functioning in Children with Down Syndrome: A Prospective Open-Label Exploratory Study of Safety and Efficacy

This Phase I open-label study evaluated the safety and potential cognitive effects of fluoxetine (10 mg/day) in 14 children with Down syndrome over 12 months, based on preclinical evidence from animal models showing hippocampal restoration. Results showed good tolerability with minor adverse events (terminal insomnia in two patients) and exploratory evidence of improvements in visuospatial processing and adaptive behavior during treatment.