Intranasal Oxytocin in Youth With Autism

Autism Spectrum Disorder Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

• NCT number: NCT05934812
• Study type: Interventional
• Source: Oslo University Hospital
• Contact: Daniel S Quintana, PhD
• Phone: +47 22 84 50 00
• Email: daniel.quintana@psykologi.uio.no
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 18, 2023
• Completion date: November 4, 2025