NCT05934812

Intranasal Oxytocin in Youth With Autism

A Randomized, Placebo-controlled, Double-blind, 2-period Cross-over Study in Youth With Autism Spectrum Disorders Evaluating Social and Repetitive Behaviors After Four Weeks of Twice Daily-doses of 24IU of Intranasally Administered Oxytocin

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

Growing evidence demonstrates the critical contribution of the neuropeptide oxytocin in the development and maintenance of autism, due to its role in social behaviour and learning processes. While some preliminary findings in oxytocin administration trials have been promising, a complete understanding of the effects of long-term oxytocin administration in autism remains elusive, as participant numbers in oxytocin administration studies in autism have been small, most studies exclusively recruit males, and reproducibility has been inconsistent. To address this critical knowledge gap, this project will include a double-blind, placebo-controlled, randomized controlled crossover trial of a four-week intranasal oxytocin treatment (24 international units, twice-daily) in 128 male and female youth with ASD aged 12-20, with social and repetitive behaviors as primary outcome measures. The investigators predict that intranasal oxytocin treatments will increase performance on social behavior measures and reduce repetitive behaviors using caregiver-reported measures. Along with the investigation of oxytocin's long-term effects, the investigators will also assess the impact of oxytocin administration on computer-based laboratory tasks that can precisely measure how participants process social cues and disengage with repetitive behaviours. In addition, an electrocardiogram will be collected to evaluate the impact of oxytocin administration on parasympathetic nervous system activity.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Oxytocin nasal spray	24IU oxytocin liquid delivered with a pump-actuated nasal spray device, administered twice-daily
DRUG	Placebo	Placebo liquid nasal spray administered twice-daily

Timeline

• Start date: 2024-09-18
• Primary completion: 2025-11-04
• Completion: 2025-11-04
• First posted: 2023-07-07
• Last updated: 2024-06-24

Locations

1 site across 1 country: Norway