Réduction de l'anxiété sociale après une psychothérapie assistée par MDMA chez des adultes autistes : une étude pilote randomisée, en double aveugle, contrôlée par placebo
Titre original en anglais : Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study
Danforth, A., Grob, C. S., Struble, C. M., Feduccia, A. A., Walker, N., Jerome, L., Yazar‐Klosinski, B., & Emerson, A. (2018). Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Psychopharmacology, 235(11), 3137-3148. https://doi.org/10.1007/s00213-018-5010-9
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Résumé
JUSTIFICATION : Les approches thérapeutiques standard visant à réduire l'anxiété sociale chez les adultes autistes ont une efficacité limitée. Étant donné que la psychothérapie assistée par 3,4-méthylènedioxyméthamphétamine (MDMA) est prometteuse comme traitement d'autres troubles anxieux, une étude pilote en aveugle, contrôlée par placebo, a été menée. OBJECTIFS : Explorer la faisabilité et la sécurité de la psychothérapie assistée par MDMA pour réduire la peur sociale et l'évitement, fréquents dans la population autiste. MÉTHODES : Des adultes autistes présentant une anxiété sociale marquée à très sévère ont été randomisés pour recevoir de la MDMA (75 à 125 mg, n = 8) ou un placebo inactif (0 mg, n = 4) lors de deux séances de psychothérapie de 8 h (séances expérimentales) dans un cadre clinique contrôlé. Les séances expérimentales en double aveugle étaient espacées d'environ 1 mois, avec 3 séances de psychothérapie sans médicament après chacune d'elles. Le critère de jugement principal était la variation des scores totaux de la Leibowitz Social Anxiety Scale (LSAS) entre l'inclusion et un mois après la deuxième séance expérimentale. Les résultats ont été mesurés de nouveau six mois après la dernière séance expérimentale. RÉSULTATS : L'amélioration des scores LSAS entre l'inclusion et le critère principal était significativement plus importante dans le groupe MDMA que dans le groupe placebo (P = 0.037), et la taille d'effet d de Cohen corrigée du placebo était très grande (d = 1.4, IC - 0.074, 2.874). La variation des scores LSAS entre l'inclusion et le suivi à 6 mois a montré des résultats positifs similaires (P = 0.036), avec une taille d'effet d de Cohen de 1.1 (IC - 0.307, 2.527). L'anxiété sociale est restée la même ou a continué à s'améliorer légèrement chez la plupart des participants du groupe MDMA après l'achèvement de la phase de traitement actif. CONCLUSIONS : Cet essai pilote a démontré une amélioration rapide et durable des symptômes d'anxiété sociale chez des adultes autistes après une psychothérapie assistée par MDMA. Les résultats initiaux relatifs à la sécurité et à l'efficacité soutiennent l'élargissement de la recherche à des échantillons plus importants afin d'étudier davantage ce nouveau traitement de l'anxiété sociale. ENREGISTREMENT DE L'ESSAI : identifiant clinicaltrials.gov, NCT02008396.
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