A Randomized Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder
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 im...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2019-11-01
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| Series: | Frontiers in Psychiatry |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fpsyt.2019.00810/full |
| _version_ | 1818279907414769664 |
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| author | Laura A. Potter Danielle A. Scholze Hazel Maridith B. Biag Andrea Schneider Andrea Schneider Andrea Schneider Yanjun Chen Danh V. Nguyen Akash Rajaratnam Susan M. Rivera Susan M. Rivera Patrick S. Dwyer Flora Tassone Flora Tassone Reem R. Al Olaby Nimrah S. Choudhary Maria J. Salcedo-Arellano Randi J. Hagerman Randi J. Hagerman |
| author_facet | Laura A. Potter Danielle A. Scholze Hazel Maridith B. Biag Andrea Schneider Andrea Schneider Andrea Schneider Yanjun Chen Danh V. Nguyen Akash Rajaratnam Susan M. Rivera Susan M. Rivera Patrick S. Dwyer Flora Tassone Flora Tassone Reem R. Al Olaby Nimrah S. Choudhary Maria J. Salcedo-Arellano Randi J. Hagerman Randi J. Hagerman |
| author_sort | Laura A. Potter |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-12T23:40:47Z |
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| id | doaj.art-2ebcac73ae3f4896a8dea6bb1ae3fa36 |
| institution | Directory Open Access Journal |
| issn | 1664-0640 |
| language | English |
| last_indexed | 2024-12-12T23:40:47Z |
| publishDate | 2019-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Psychiatry |
| spelling | doaj.art-2ebcac73ae3f4896a8dea6bb1ae3fa362022-12-22T00:07:11ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402019-11-011010.3389/fpsyt.2019.00810481783A Randomized Controlled Trial of Sertraline in Young Children With Autism Spectrum DisorderLaura A. Potter0Danielle A. Scholze1Hazel Maridith B. Biag2Andrea Schneider3Andrea Schneider4Andrea Schneider5Yanjun Chen6Danh V. Nguyen7Akash Rajaratnam8Susan M. Rivera9Susan M. Rivera10Patrick S. Dwyer11Flora Tassone12Flora Tassone13Reem R. Al Olaby14Nimrah S. Choudhary15Maria J. Salcedo-Arellano16Randi J. Hagerman17Randi J. Hagerman18Medical Investigation of Neurodevelopmental Disorders (MIND) Institute, UC Davis Health, Sacramento, CA, United StatesDepartment of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, WI, United StatesMedical Investigation of Neurodevelopmental Disorders (MIND) Institute, UC Davis Health, Sacramento, CA, United StatesMedical Investigation of Neurodevelopmental Disorders (MIND) Institute, UC Davis Health, Sacramento, CA, United StatesDepartment of Pediatrics, UC Davis Health, Sacramento, CA, United StatesCollege of Psychology, California Northstate University, Elk Grove, CA, United StatesInstitute for Clinical and Translational Science, University of California, Irvine, Irvine, CA, United StatesDepartment of Medicine, University of California, Irvine School of Medicine, Orange, CA, United StatesCase Western Reserve University School of Medicine, Cleveland, OH, United StatesMedical Investigation of Neurodevelopmental Disorders (MIND) Institute, UC Davis Health, Sacramento, CA, United StatesDepartment of Psychiatry and Behavioral Sciences, UC Davis Health, Sacramento, CA, United StatesDepartment of Psychology, University of California, Davis, Davis, CA, United StatesMedical Investigation of Neurodevelopmental Disorders (MIND) Institute, UC Davis Health, Sacramento, CA, United States0Department of Biochemistry and Molecular Medicine, UC Davis Health, Sacramento, CA, United States1College of Health Sciences, California Northstate University, Rancho Cordova, CA, United States0Department of Biochemistry and Molecular Medicine, UC Davis Health, Sacramento, CA, United StatesMedical Investigation of Neurodevelopmental Disorders (MIND) Institute, UC Davis Health, Sacramento, CA, United StatesMedical Investigation of Neurodevelopmental Disorders (MIND) Institute, UC Davis Health, Sacramento, CA, United StatesDepartment of Pediatrics, UC Davis Health, Sacramento, CA, United StatesObjective: 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.https://www.frontiersin.org/article/10.3389/fpsyt.2019.00810/fullsertralineautism spectrum disordercontrolled trialtargeted treatmentnonsyndromic autism spectrum disorder |
| spellingShingle | Laura A. Potter Danielle A. Scholze Hazel Maridith B. Biag Andrea Schneider Andrea Schneider Andrea Schneider Yanjun Chen Danh V. Nguyen Akash Rajaratnam Susan M. Rivera Susan M. Rivera Patrick S. Dwyer Flora Tassone Flora Tassone Reem R. Al Olaby Nimrah S. Choudhary Maria J. Salcedo-Arellano Randi J. Hagerman Randi J. Hagerman A Randomized Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder Frontiers in Psychiatry sertraline autism spectrum disorder controlled trial targeted treatment nonsyndromic autism spectrum disorder |
| title | A Randomized Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder |
| title_full | A Randomized Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder |
| title_fullStr | A Randomized Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder |
| title_full_unstemmed | A Randomized Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder |
| title_short | A Randomized Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder |
| title_sort | randomized controlled trial of sertraline in young children with autism spectrum disorder |
| topic | sertraline autism spectrum disorder controlled trial targeted treatment nonsyndromic autism spectrum disorder |
| url | https://www.frontiersin.org/article/10.3389/fpsyt.2019.00810/full |
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