A randomized, double-blind, placebo-controlled trial of low-dose sertraline in young children with fragile X syndrome
Open accessAbstract
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 of treatment with low-dose sertraline in a randomized, double-blind, placebo-controlled trial in 52 children with FXS aged 2 to 6 years. RESULTS: Eighty-one subjects were screened for eligibility, and 57 were randomized to sertraline (27) or placebo (30). Two subjects from the sertraline arm and 3 from the placebo arm discontinued. Intent-to-treat analysis showed no difference from placebo on the primary outcomes: the Mullen Scales of Early Learning (MSEL) expressive language (EL) age equivalent and Clinical Global Impression Scale-Improvement. However, analyses of secondary measures showed significant improvements, particularly in motor and visual perceptual abilities and social participation. Sertraline was well tolerated, with no difference in side effects between sertraline and placebo groups. No serious adverse events occurred. CONCLUSION: This randomized controlled trial of 6 months of sertraline treatment showed no primary benefit with respect to early EL development and global clinical improvement. However, in secondary exploratory analyses, there were significant improvements seen on motor and visual perceptual subtests, the cognitive T score sum on the MSEL, and on one measure of social participation on the Sensory Processing Measure-Preschool. Furthermore, post hoc analysis found significant improvement in early EL development as measured by the MSEL among children with autism spectrum disorder on sertraline. Treatment appears safe for this 6-month period in young children with FXS, but the authors do not know the long-term side effects of this treatment. These results warrant further studies of sertraline in young children with FXS using refined outcome measures as well as longer term follow-up studies to address long-term side effects of low-dose sertraline in early childhood.
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Post-hoc analysis of the sertraline trial showed that patients with both autism spectrum disorder and fragile X syndrome receiving sertraline improved on the Expressive Language subtest compared with placebo.
“Post-hoc analysis demonstrated that patients with ASD and FXS receiving sertraline showed improvements in the Expressive Language subtest compared with patients receiving placebo100.”
From Drug development for neurodevelopmental disorders: lessons learned from fragile X syndrome (2018) · cites this paper as [100]
In the sertraline trial, secondary exploratory analyses showed improvements in the Visual Reception and Fine Motor subtests of the Mullen Scales of Early Learning in the sertraline group compared with placebo.
“the secondary exploratory analyses — specifically the Visual Reception and Fine Motor subtests of the MSEL — demonstrated improvements in the group receiving sertraline compared with patients receiving placebo.”
From Drug development for neurodevelopmental disorders: lessons learned from fragile X syndrome (2018) · cites this paper as [100]
In a double-blind placebo-controlled trial in 57 children with fragile X syndrome aged 2 to 6 years, sertraline produced no improvements in the primary outcomes, the CGI-I or the Expressive Language subtest of the Mullen Scales of Early Learning.
“There were no improvements in primary outcome measures, the CGI-I or the Expressive Language subtest of the Mullen Scales of Early Learning (MSEL).”
From Drug development for neurodevelopmental disorders: lessons learned from fragile X syndrome (2018) · cites this paper as [100]
In a controlled trial of sertraline in children ages 2 to 6 with FXS (60% also had ASD), those treated with sertraline demonstrated greater improvement in motor and visual subtests and the Cognitive T score on the MSEL compared to those on placebo.
“Those treated with sertraline demonstrated greater improvement in motor and visual subtests and the Cognitive T score on the MSEL compared to those on placebo.”
From An Update on Psychopharmacological Treatment of Autism Spectrum Disorder (2022) · cites this paper as [36]
In children with both FXS and ASD, there was significant improvement on the Expressive Language subscale compared to placebo.
“In the children with both FXS and ASD, there was also significant improvement on the Expressive Language subscale compared to placebo [36].”
From An Update on Psychopharmacological Treatment of Autism Spectrum Disorder (2022) · cites this paper as [36]
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Self-citationA randomized controlled trial of sertraline in young children with autism spectrum disorder
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Self-citation
- Authors
- Greiss Hess, L., Fitzpatrick, S. E., Nguyen, D. V., Chen, Y., Gaul, K. N., Schneider, A., Lemons Chitwood, K., Eldeeb, M. A. A. A., Polussa, J., Hessl, D., Rivera, S., & Hagerman, R. J.
- Affiliations
- Medical Investigation of Neurodevelopmental Disorders (MIND) Institute, University of California, Davis Medical Center, Sacramento, CA;
- University of California Davis Medical Center (US)
- University of California, Irvine (US)
- Corresponding author
- Fitzpatrick, Sarah E.
- Gaul, Kimberly N.
- Schneider, Andrea
- Polussa, Jonathan
- Hessl, David
- Rivera, Susan
- Hagerman, Randi J.
- ORCID
- Venue
- Journal of Developmental & Behavioral Pediatrics
- Published
- 2016-10
- Volume
- 37
- Issue
- 8
- Pages
- 619-628
- ISSN
- 0196-206X (ISSN-L)
- PMC
- PMC5039060
- OpenAlex
- W2518541914
- Cited by
- 122
- References
- 53
- Citations by year
- 2026: 6 · 2025: 5 · 2024: 14 · 2023: 5 · 2022: 7 · 2021: 11 · 2020: 41 · 2019: 12 · 2018: 3 · 2017: 15 · 2016: 1
- FWCI
- 8.35
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Developmental & Behavioral Pediatrics (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Dominican Scholar (Dominican University of California) (submittedVersion)
- Funders
- National Institutes of Health (UL1TR000002, UL1TR001414, TL1TR000133, UL1TR000153)
- National Center for Advancing Translational Sciences
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (U54HD079125)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Genetics and Neurodevelopmental Disorders
- Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
- Life Sciences › Neuroscience › Developmental Neuroscience › Williams Syndrome Research
- Keywords
- sertraline, fragile X syndrome, selective serotonin reuptake inhibitors, young children, expressive language development, motor development, visual-perceptual abilities, social participation (health and rehabilitation), autism spectrum disorder, sensory processing, treatment safety
- MeSH terms
- Child, Child, Preschool, Double-Blind Method, Female, Fragile X Syndrome, Humans, Male, Outcome Assessment, Health Care, Selective Serotonin Reuptake Inhibitors, Sertraline
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