Design of the Largest Clinical Trial of Oxytocin for Autism Social Behavior
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.
Quick Facts
What This Study 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.
Key Numbers
n=290; ages 3-17; 7 sites; 24 weeks double-blind + 24 weeks open-label; plasma oxytocin and OXTR methylation measured
How They Did This
Phase 2 randomized, placebo-controlled, multi-site clinical trial with 24 weeks blinded treatment, 24 weeks open-label extension, and biomarker measurements.
Why This Research 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 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.
What This Study Doesn't Tell Us
Design paper only — no results reported. Trial outcomes are not yet available in this publication.
Questions This Raises
- ?Will intranasal oxytocin produce clinically meaningful improvements in social behavior?
- ?Which biomarkers predict oxytocin treatment response in ASD?
- ?Are effects sustained after treatment discontinuation?
Trust & Context
- Key Stat:
- 290 children Enrolled in the most well-powered trial of intranasal oxytocin for autism to date
- Evidence Grade:
- Trial design paper describing methodology only, with no efficacy results. The design is rigorous (randomized, placebo-controlled, multi-site).
- Study Age:
- Published in 2020 as a design paper. Results from SOARS-B have since been published.
- Original Title:
- Rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).
- Published In:
- Contemporary clinical trials, 98, 106103 (2020)
- Authors:
- Spanos, Marina(2), Chandrasekhar, Tara(2), Kim, Soo-Jeong(2), Hamer, Robert M, King, Bryan H, McDougle, Christopher J, Sanders, Kevin B, Gregory, Simon G, Kolevzon, Alexander, Veenstra-VanderWeele, Jeremy, Sikich, Linmarie
- Database ID:
- RPEP-05147
Evidence Hierarchy
Frequently Asked 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 More on RethinkPeptides
Cite This Study
https://rethinkpeptides.com/research/RPEP-05147APA
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
MLA
Spanos, Marina, et al. "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, 2020. https://doi.org/10.1016/j.cct.2020.106103
RethinkPeptides
RethinkPeptides Research Database. "Rationale, design, and methods of the Autism Centers of Exce..." RPEP-05147. Retrieved from https://rethinkpeptides.com/research/spanos-2020-rationale-design-and-methods
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkPeptides research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.