A Randomized, Double-Blind, Placebo-Controlled Trial of Low-Dose Sertraline in Young Children With Fragile X Syndrome.

摘要: Objective Observational studies and anecdotal reports suggest that sertraline, a selective serotonin reuptake inhibitor, may improve language development in young children with fragile X syndrome (FXS). Methods The authors evaluated the efficacy of 6 months treatment low-dose sertraline randomized, double-blind, placebo-controlled trial 52 FXS aged 2 to years. Results Eighty-one subjects were screened for eligibility, 57 randomized (27) or placebo (30). Two from arm 3 discontinued. Intent-to-treat analysis showed no difference on primary outcomes: Mullen Scales Early Learning (MSEL) expressive (EL) age equivalent Clinical Global Impression Scale-Improvement. However, analyses secondary measures significant improvements, particularly motor visual perceptual abilities social participation. Sertraline was well tolerated, side effects between groups. No serious adverse events occurred. Conclusion This controlled benefit respect early EL global clinical improvement. exploratory analyses, there improvements seen subtests, cognitive T score sum MSEL, one measure participation Sensory Processing Measure-Preschool. Furthermore, post hoc found improvement as measured by MSEL among autism spectrum disorder sertraline. Treatment appears safe this 6-month period FXS, but do not know long-term treatment. These results warrant further using refined outcome longer term follow-up address childhood.