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.
| Original language | English (US) |
|---|---|
| Article number | 810 |
| Journal | Frontiers in Psychiatry |
| Volume | 10 |
| DOIs | |
| State | Published - Nov 6 2019 |
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Keywords
- autism spectrum disorder
- controlled trial
- nonsyndromic autism spectrum disorder
- sertraline
- targeted treatment
ASJC Scopus subject areas
- Psychiatry and Mental health
Cite this
A Randomized Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder. / Potter, Laura A.; Scholze, Danielle A.; Biag, Hazel Maridith B.; Schneider, Andrea; Chen, Yanjun; Nguyen, Danh V.; Rajaratnam, Akash; Rivera, Susan M.; Dwyer, Patrick S.; Tassone, Flora; Al Olaby, Reem R.; Choudhary, Nimrah S.; Salcedo-Arellano, Maria J.; Hagerman, Randi J.
In: Frontiers in Psychiatry, Vol. 10, 810, 06.11.2019.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A Randomized Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder
AU - Potter, Laura A.
AU - Scholze, Danielle A.
AU - Biag, Hazel Maridith B.
AU - Schneider, Andrea
AU - Chen, Yanjun
AU - Nguyen, Danh V.
AU - Rajaratnam, Akash
AU - Rivera, Susan M.
AU - Dwyer, Patrick S.
AU - Tassone, Flora
AU - Al Olaby, Reem R.
AU - Choudhary, Nimrah S.
AU - Salcedo-Arellano, Maria J.
AU - Hagerman, Randi J.
PY - 2019/11/6
Y1 - 2019/11/6
N2 - 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.
AB - 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.
KW - autism spectrum disorder
KW - controlled trial
KW - nonsyndromic autism spectrum disorder
KW - sertraline
KW - targeted treatment
UR - http://www.scopus.com/inward/record.url?scp=85075545177&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85075545177&partnerID=8YFLogxK
U2 - 10.3389/fpsyt.2019.00810
DO - 10.3389/fpsyt.2019.00810
M3 - Article
AN - SCOPUS:85075545177
VL - 10
JO - Frontiers in Psychiatry
JF - Frontiers in Psychiatry
SN - 1664-0640
M1 - 810
ER -