Design of the Largest Clinical Trial of Oxytocin for Autism Social Behavior | Research

The takeaway

SOARS-B is the most well-powered clinical trial to date testing whether intranasal oxytocin can improve social behaviors in children with autism spectrum disorder.

290 children
Enrolled in the most well-powered trial of intranasal oxytocin for autism to date

What the researchers found

SOARS-B enrolled 290 participants across seven sites for a 24-week randomized trial of intranasal oxytocin in ASD, making it the best-powered study to date.

Why it matters

Previous small oxytocin-autism studies produced conflicting results. This large trial aims to definitively determine whether intranasal oxytocin improves social behaviors in children with ASD.

The numbers in context

n=290; ages 3-17; 7 sites; 24 weeks double-blind + 24 weeks open-label; plasma oxytocin and OXTR methylation measured

How the study worked

Phase 2 randomized, placebo-controlled, multi-site clinical trial with 24 weeks blinded treatment, 24 weeks open-label extension, and biomarker measurements.

Who was studied

290 children and teens ages 3-17 with ASD across 7 US sites

What this study cannot tell us

Design paper only — no results reported. Trial outcomes are not yet available in this publication.

How to read the evidence

Trial design paper describing methodology only, with no efficacy results. The design is rigorous (randomized, placebo-controlled, multi-site).

When this study was published

Published in 2020 as a design paper. Results from SOARS-B have since been published.

The bigger picture

This trial represents the most rigorous test of the oxytocin hypothesis for autism treatment, promising to either validate a new approach or redirect research efforts.

Questions still open

Will intranasal oxytocin produce clinically meaningful improvements in social behavior?
Which biomarkers predict oxytocin treatment response in ASD?
Are effects sustained after treatment discontinuation?

Common questions

Why is oxytocin being tested for autism?

Oxytocin is a neuropeptide involved in social bonding and trust. Research suggests it may enhance social attention and reward in people with autism, potentially improving social interaction. However, previous small studies had mixed results.

What makes this trial different from earlier studies?

SOARS-B is much larger (290 children vs. dozens in prior studies), longer (48 weeks total), and conducted across 7 sites, giving it statistical power to detect effects that smaller studies could not.

Read the original research

Rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).

Contemporary clinical trials, 98, 106103

View on PubMed ↗Publisher’s paper ↗

Citation

Spanos, Marina; Chandrasekhar, Tara; Kim, Soo-Jeong; Hamer, Robert M; King, Bryan H; McDougle, Christopher J; Sanders, Kevin B; Gregory, Simon G; Kolevzon, Alexander; Veenstra-VanderWeele, Jeremy; Sikich, Linmarie. (2020). Rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).. Contemporary clinical trials, 98, 106103. https://doi.org/10.1016/j.cct.2020.106103