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

Datos Bibliográficos

ID15524596
AutoresLaura A Potter (0000-0001-6912-9214, University of California, Davis, autor de correspondencia), Danielle A Scholze (University of Wisconsin–Madison), Hazel Maridith Barlahan Biag (0000-0003-1786-5847, University of California, Davis), Andrea Schneider (0000-0002-9630-875X, UC Davis Health System), Yanjun Chen (0000-0002-6825-9460, University of California, Irvine), Danh V Nguyen (0000-0002-4025-8239, University of California, Irvine), Akash Rajaratnam (Case Western Reserve University), Susan M Rivera (0000-0002-4870-4774, UC Davis Health System), Patrick Dwyer (0000-0003-1779-5252, University of California, Davis), Flora Tassone (0000-0002-6388-9180, UC Davis Health System), Reem R Al Olaby (California Northstate University), Nimrah S Choudhary (UC Davis Health System), María Jimena Salcedo‐Arellano (0000-0002-2412-9146, University of California, Davis), Randi J Hagerman (0000-0001-5029-8448, UC Davis Health System)
Año2019
Volumen10
Páginas810-810
Fecha de publicación2019-11-06
Peer ReviewedSí
Open AccessSí
TipoARTICLE
RevistaFrontiers in Psychiatry (JOURNAL)
Identificadores de la revistaISSN: 1664-0640 • E-ISSN: 1664-0640
EditorialFrontiers Media (PUBLISHER • CH)
DOI10.3389/fpsyt.2019.00810
PMID31780970
OpenAlexW2986093041
IdiomaEN
Citas recibidas1
Referencias citadas5

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

Adverse effect · Antidepressant · Anxiety · Autism · Autism spectrum disorder · Placebo · Post-hoc analysis · Psychiatry · Randomized controlled trial · Sertraline · Autism Spectrum Disorder Research · Child Nutrition and Feeding Issues · Clinical Psychology · Genetics and Neurodevelopmental Disorders · Medicine · Psychology · Internal Medicine · Pediatrics