A randomized controlled trial of sertraline in young children with autism spectrum disorder
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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. Clinicaltrials.gov Identifier: NCT02385799
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A similar study in young children ages 2 to 6 with idiopathic ASD (without FXS) treated with low-dose sertraline did not demonstrate a benefit of sertraline compared to placebo.
“However, a similar study in young children ages 2 to 6 with idiopathic ASD (without FXS) treated with low-dose sertraline did not demonstrate a benefit of sertraline compared to placebo [38].”
From An Update on Psychopharmacological Treatment of Autism Spectrum Disorder (2022) · cites this paper as [38]
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Thys, H., MARCHE, W. D. L., & DANCKAERTS, M. (2026) · Tijdschrift voor Geneeskunde · doi:10.47671/tvg.82.26.025
POWERS, J. H., Thom, R. P., & McDougle, C. J. (2026) · doi:10.1002/9781394389933.ch24
- Authors
- Potter, L. A., Scholze, D. A., Biag, H. M. B., Schneider, A., Chen, Y., Nguyen, D. V., Rajaratnam, A., Rivera, S. M., Dwyer, P. S., Tassone, F., Al Olaby, R. R., Choudhary, N. S., Salcedo-Arellano, M. J., & Hagerman, R. J.
- Affiliations
- University of California Davis Medical Center (US)
- University of Wisconsin–Madison (US)
- California Northstate University (US)
- University of California, Irvine (US)
- Case Western Reserve University (US)
- University of California, Davis (US)
- Corresponding author
- Potter, Laura A.
- ORCID
- Venue
- Frontiers in Psychiatry
- Publisher
- Frontiers Media SA
- Published
- 2019-11-06
- Volume
- 10
- Pages
- 810-810
- ISSN
- 1664-0640 (ISSN-L)
- PMC
- PMC6851992
- OpenAlex
- W2986093041
- Cited by
- 43
- References
- 49
- Citations by year
- 2026: 6 · 2025: 6 · 2024: 6 · 2023: 7 · 2022: 7 · 2021: 6 · 2020: 5
- FWCI
- 2.62
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Frontiers in Psychiatry (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- Health Resources and Services Administration
- National Institute of Child Health and Human Development
- National Institutes of Health
- Topics
- Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Genetics and Neurodevelopmental Disorders
- Health Sciences › Medicine › Psychiatry and Mental health › Child Nutrition and Feeding Issues
- Keywords
- sertraline, autism spectrum disorder, young children, selective serotonin reuptake inhibitors, expressive language development, Mullen Scales of Early Learning, drug efficacy, drug safety, adverse events
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