Systematic review of randomized clinical trials testing a pharmacological treatment in adults with autism spectrum disorder

Author:

Miguel Alicia Pérez1,Moreno Mª Luisa Sánchez de Ocaña2,Peiró Ana María Peiró1,Gisbert Laura3,Lugo-Marín Jorge3,Martínez-Cayuelas Elena4,Ballester Pura5ORCID

Affiliation:

1. UMH: Universidad Miguel Hernandez de Elche

2. UCAM: Universidad Catolica San Antonio de Murcia

3. Vall d'Hebron Hospital: Hospital Universitari Vall d'Hebron

4. Fundación Jiménez Díaz: Hospital Universitario Fundacion Jimenez Diaz

5. Universidad Católica San Antonio de Murcia: Universidad Catolica San Antonio de Murcia

Abstract

Abstract Introduction: Autism Spectrum Disorder (ASD) affects 1 in 68 newborns. ASD is a neurodevelopmental condition characterized by deficits in social interaction, communication, and presence of restricted and repetitive interests. Despite this high prevalence and burden, there is no approved treatment for ASD’ core symptoms. Objective: This systematic review, using a rigorous methodological design, attempts to collect all clinical trials in adults with ASD have been published. Methods: To ensure the retrieval of a maximum of articles, the systematic review used the databases Medline and Scopus. Retrieved manuscripts were evaluated reading the title, keywords, and abstract. CONSORT guidelines were used to evaluate the quality of included manuscripts (0-100% scale). Results: A total of 17/86 (20%) clinical trials were selected with an average score of 70% in CONSORT. In general, sample sizes were low, ranged from 30 (single-center studies) to 115 participants (multiple inclusion sites), and an average age of 27 years-old. Pharmacological treatments studied were for improving a) social interaction and attachment (propranolol, oxytocin); b) cognitive abilities (cannabidiol); c) behavior (naltrexone, vasopressin V1a antagonists, dextromethorphan, quinidine, agomelatine, and citalopram); d) facial expression and emotion recognition (citalopram oxytocin, and V1a receptor antagonist). Conclusion: regardless the methodological quality, there are few studies in this field with a low number of participants. Furthermore, different designs and measures to assess efficacy are used, and that avoids comparisons between them. Therefore, it is necessary to raise awareness in this field, and increase the number of clinical trials in the future with long-term side-effect monitoring.

Publisher

Research Square Platform LLC

Reference54 articles.

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2. Lai MC, Lombardo M V., Baron-Cohen S. Autism. In: The Lancet [Internet]. Elsevier B.V.; 2014 [cited 2021 Apr 24]. p. 896–910. Available from: http://dx.doi.org/10.1016/

3. Brugha TS, Spiers N, Bankart J, Cooper SA, McManus S, Scott FJ, et al. Epidemiology of autism in adults across age groups and ability levels. Br J Psychiatry [Internet]. 2016 Dec 1 [cited 2021 Apr 25];209(6):498–503. Available from: https://www.cambridge.org/core.

4. Prevalence of autism spectrum disorder among children aged 8 Years - Autism and developmental disabilities monitoring network, 11 Sites, United States, 2014;Baio J;MMWR Surveill Summ,2018

5. Wink LK, Plawecki MH, Erickson CA, Stigler KA, McDougle CJ. Emerging drugs for the treatment of symptoms associated with autism spectrum disorders [Internet]. Vol. 15, Expert Opinion on Emerging Drugs. NIH Public Access; 2010 [cited 2021 May 20]. p. 481–94. Available from: /pmc/articles/PMC2923687/

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