A Randomized Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder

摘要: Objective: Selective serotonin reuptake inhibitors like sertraline have been shown in observational studies and anecdotal reports to improve language development young children with fragile X syndrome (FXS). A previous controlled trial of FXS found significant improvement expressive as measured by the Mullen Scales Early Learning (MSEL) among those comorbid autism spectrum disorder (ASD) post hoc analysis, prompting authors probe whether is also indicated nonsyndromic ASD. Methods: The evaluated efficacy 6 months treatment low-dose a randomized, double-blind, placebo-controlled 58 ASD aged 24 72 months. Results: 179 subjects were screened for eligibility, randomized (32) or placebo (26). Eight from arm five discontinued. Intent-to-treat analysis showed no difference on primary outcomes (MSEL raw score age equivalent combined score) secondary outcomes. Sertraline was well tolerated, side effects between groups. No serious adverse events possibly related study occurred. Conclusion: This benefit respect outcome measures. For 6-month period, appears safe, although long-term early childhood are unknown. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02385799.