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Randomized Controlled Trial
. 2024 Jan;241(1):19-32.
doi: 10.1007/s00213-023-06452-1. Epub 2023 Dec 13.

Randomized controlled trial of propranolol on social communication and anxiety in children and young adults with autism spectrum disorder

David Q Beversdorf  1   2   3 , Bradley Ferguson  4   5 , Samantha Hunter  4 , Kathy Hirst  4 , Bridget Lolli  4 , Katherine R Bellesheim  6 , Amy U Barton  7 , Julie Muckerman  4 , Nicole Takahashi  4 , Kimberly Selders  4 , Ryan Holem  4   8 , Kristin Sohl  9 , Peter Dyke  9 , Janine Stichter  10 , Micah Mazurek  11 , Stephen Kanne  12
Affiliations
Randomized Controlled Trial

Randomized controlled trial of propranolol on social communication and anxiety in children and young adults with autism spectrum disorder

David Q Beversdorf et al. Psychopharmacology (Berl). 2024 Jan.

Abstract

Rationale: Autism spectrum disorder (ASD) is characterized by impaired social communication and is also frequently characterized by co-occurring anxiety. Propranolol is widely utilized to treat performance and public speaking anxiety. Single-dose psychopharmacological challenge studies suggested benefits using propranolol for verbal tasks and social interaction.

Objective: We conducted a double-blinded, placebo-controlled trial of the β-adrenergic antagonist propranolol in ASD for social interaction, anxiety, and language.

Methods: Seventy-four participants with ASD, age 7-24 years, were enrolled and randomized to a 12-week course of propranolol or placebo, with blinded assessments at baseline, 6 weeks, and 12 weeks. The primary outcome was the General Social Outcome Measure-2 (GSOM-2) for social interaction, and secondary outcomes were the Clinician Global Clinical Impression-Improvement (CGI-I) ratings independently conducted for social interaction, anxiety, and language at 6 weeks and 12 weeks.

Results: Sixty-nine participants completed the 12-week visit. No significant effect of drug was found for the GSOM-2 or the CGI-I for social interaction or language. CGI-I for anxiety showed greater improvement with propranolol at the 12-week time point (p = 0.045, odds ratio = 2.58 (95% CI = 1.02-6.52). Expected decreases in heart rate and blood pressure were observed with propranolol, and side effects were uncommon.

Conclusions: Propranolol did not impact social interaction measures or language, but there were indications of a beneficial effect for anxiety. This will need confirmation in a larger multicenter trial, monitoring markers or characteristics to identify those participants most likely to respond to propranolol for anxiety, and determine whether there is a subset of participants that are responsive for other previously reported outcomes.

Keywords: Adrenergic; Anxiety; Autism; Clinical trial; Propranolol; Social.

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References

    1. Alexander JK, Hillier A, Smith RM, Tivarus ME, Beversdorf DQ (2007) Noradrenergic modulation of cognitive flexibility during stress. J Cogn Neurosci 19:468–478. https://doi.org/10.1097/00001756-199909090-00012 - DOI - PubMed
    1. Aman MG, Singh NN, Stewart AW, Fields CJ (1985) The Aberrant Behavior Checklist: a behavior rating scale for the assessment of treatment effects. Am J Mental Defic 89:485–491
    1. American Psychological Association (2013) Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V). American Psychological Association, Washington, DC. https://doi.org/10.1176/appi.books.9780890425596 - DOI
    1. Barthelemy C, Bruneau N, Cottet-Eymard JM, Domenech-Jouve J, Garreau B, Lelord G, Muh JP, Peyrin L (1988) Urinary free and conjugated catecholamines and metabolites in autistic children. J Autism Devel Disord 18:583–591. https://doi.org/10.1007/BF02211876 - DOI
    1. Beversdorf DQ (2020) The role of the noradrenergic system in autism spectrum disorders, implications for treatment. Semin Pediatr Neurol 35:100834. https://doi.org/10.1016/j.spen.2020.100834 - DOI - PMC

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