Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Nov 6:10:810.
doi: 10.3389/fpsyt.2019.00810. eCollection 2019.

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

Laura A Potter  1 , Danielle A Scholze  2 , Hazel Maridith B Biag  1 , Andrea Schneider  1   3   4 , Yanjun Chen  5 , Danh V Nguyen  6 , Akash Rajaratnam  7 , Susan M Rivera  1   8 , Patrick S Dwyer  9 , Flora Tassone  1   10 , Reem R Al Olaby  11 , Nimrah S Choudhary  10 , Maria J Salcedo-Arellano  1 , Randi J Hagerman  1   3
Affiliations

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

Laura A Potter et al. Front Psychiatry. .

Abstract

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.

Keywords: autism spectrum disorder; controlled trial; nonsyndromic autism spectrum disorder; sertraline; targeted treatment.

PubMed Disclaimer

Figures

Figure 1
Figure 1
CONSORT flow diagram. CONSORT, Consolidated Standards of Reporting Trials.
Figure 2
Figure 2
Clinical Global Impression Scale—Improvement at end-of-treatment. CGI-I, Clinical Global Impression Scale—Improvement.
See this image and copyright information in PMC

References

    1. Youssef EA, Berry-Kravis E, Czech C, Hagerman RJ, Hessl D, Wong CY, et al. Effect of the mGluR5-NAM Basimglurant on Behavior in Adolescents and Adults with Fragile X Syndrome in a Randomized, Double-Blind, Placebo-Controlled Trial: FragXis Phase 2 Results. Neuropsychopharmacology (2018) 43(3):503–12. 10.1038/npp.2017.177 - DOI - PMC - PubMed
    1. De Rubeis S, He X, Goldberg AP, Poultney CS, Samocha K, Cicek AE, et al. Synaptic, transcriptional and chromatin genes disrupted in autism. Nature (2014) 515(7526):209–15. 10.1038/nature13772 - DOI - PMC - PubMed
    1. Baio J, Wiggins L, Christensen DL, Maenner MJ, Daniels J, Warren Z, et al. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2014. Mmwr Surveill Summ (2018) 67(6):1–23. 10.15585/mmwr.ss6706a1 - DOI - PMC - PubMed
    1. Iossifov I, O'Roak BJ, Sanders SJ, Ronemus M, Krumm N, Levy D, et al. The contribution of de novo coding mutations to autism spectrum disorder. Nature (2014) 515:216. 10.1038/nature13908 - DOI - PMC - PubMed
    1. Iossifov I, Ronemus M, Levy D, Wang Z, Hakker I, Rosenbaum J, et al. De novo gene disruptions in children on the autistic spectrum. Neuron (2012) 74(2):285–99. 10.1016/j.neuron.2012.04.009 - DOI - PMC - PubMed

Associated data