Un essai contrôlé randomisé de la sertraline chez de jeunes enfants atteints de trouble du spectre de l’autisme

Titre original en anglais : A Randomized Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder

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Potter, L. A., Scholze, D. A., Biag, H. M. B., Schneider, A., Chen, Y., Nguyen, D. V., Rajaratnam, A., Rivera, S. M., Dwyer, P., Tassone, F., Olaby, R. R. A., Choudhary, N. S., Salcedo‐Arellano, M. J., & Hagerman, R. J. (2019). A Randomized Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder. Frontiers in Psychiatry, 10, 810-810. https://doi.org/10.3389/fpsyt.2019.00810

Date de publication: 06/11/2019 Ajout dans AutiHub: 05/07/2026 Type: Article Langue de l’article: Anglais
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Auteurs

Auteur·ices des publications
14
Auteur·ices de la publication identifié·es comme autistes
1 / 14 (7,1 %)
  1. Laura A. Potter
  2. Danielle A. Scholze
  3. Hazel Maridith Barlahan Biag
  4. Andrea Schneider
  5. Yanjun Chen
  1. Danh V. Nguyen
  2. Akash Rajaratnam
  3. Susan M. Rivera
  4. Patrick Dwyer *
  5. Flora Tassone
  1. Reem R. Al Olaby
  2. Nimrah S. Choudhary
  3. María Jimena Salcedo‐Arellano
  4. Randi J. Hagerman

Résumé

Objectif : Il a été montré, dans des études observationnelles et des rapports anecdotiques, que les inhibiteurs sélectifs de la recapture de la sérotonine tels que la sertraline améliorent le développement du langage chez de jeunes enfants atteints du syndrome de l’X fragile (FXS). Un précédent essai contrôlé de la sertraline chez de jeunes enfants atteints de FXS a constaté une amélioration significative du développement du langage expressif, telle que mesurée par les Mullen Scales of Early Learning (MSEL), chez ceux présentant un trouble du spectre de l’autisme (TSA) comorbide lors d’une analyse post hoc, ce qui a incité les auteurs à examiner si la sertraline est également indiquée dans le TSA non syndromique. Méthodes : Les auteurs ont évalué l’efficacité de 6 mois de traitement par sertraline à faible dose dans un essai randomisé, en double aveugle, contrôlé contre placebo, chez 58 enfants atteints de TSA âgés de 24 à 72 mois. Résultats : Cent soixante-dix-neuf sujets ont été évalués quant à leur admissibilité, et 58 ont été randomisés pour recevoir de la sertraline (32) ou un placebo (26). Huit sujets du groupe sertraline et cinq du groupe placebo ont arrêté l’étude. L’analyse en intention de traiter n’a montré aucune différence significative par rapport au placebo concernant les critères de jugement principaux (score brut de langage expressif MSEL et score combiné d’équivalent d’âge) ni les critères de jugement secondaires. La sertraline a été bien tolérée, sans différence d’effets indésirables entre les groupes sertraline et placebo. Aucun événement indésirable grave possiblement lié au traitement de l’étude ne s’est produit. Conclusion : Cet essai contrôlé randomisé du traitement par sertraline n’a montré aucun bénéfice concernant les mesures des critères de jugement principaux ou secondaires. Pendant la période de 6 mois, le traitement chez de jeunes enfants atteints de TSA semble sûr, bien que les effets indésirables à long terme de la sertraline à faible dose durant la petite enfance soient inconnus. Identifiant ClinicalTrials.gov : NCT02385799

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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Références citées
52
Nombre total de références citées intégrées pour cette publication.
Références citées avec un·e auteur·ice identifié·e comme autiste
0 / 52 (0,0 %)
Occurrences d’auteur·ices cité·es identifié·es comme autistes
0 / 669 (0,0 %)
Parmi les occurrences rattachées à des auteurices intégré·es à la base de données AutiHub : 0 / 63 (0,0 %). Auteurices cité·es distinct·es identifié·es comme autistes : 0 / 606 (0,0 %).
Occurrences citées rattachées à la base AutiHub
63 / 669 (9,4 %)
Auteurices cité·es distinct·es rattaché·es : 37 / 606 (6,1 %)
Occurrences rattachées, non identifiées comme autistes
63 / 63 (100,0 %)
Parmi les seules occurrences rattachées. Sur l’ensemble des occurrences d’auteurices cité·es : 63 / 669 (9,4 %). Auteurices cité·es distinct·es rattaché·es, non identifié·es comme autistes : 37 / 37 (100,0 %).
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