Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors — SOARS-B  

Autism Spectrum Disorders Clinical Trial

Official title: Phase II Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors

Status Completed

Clinical Trial Summary

The purpose of this research study is to learn about the effects of supplemental intranasal oxytocin as a treatment for improving social difficulties in children and adolescents with autism. This study will also provide additional information about the safety and tolerability of intranasal oxytocin. Investigators expect oxytocin will increase social motivation, improving daily living skills and quality of life.

Clinical Trial Description

There is a tremendous unmet need for accessible treatments that address core symptoms of ASD and are safe for sustained use. The Study of Oxytocin in ASD to improve Reciprocal Social Behaviors or (SOARS-B) will test a very promising potential treatment-intranasal oxytocin-for ASD's fundamental social communication deficits in a large, group of verbal and nonverbal children. SOARS-B will also provide information about the regulation of DNA methylation and transcription of the oxytocin receptor gene (OXTR), as well as other genes relevant to oxytocin's CNS activity, as a function of time and in response to oxytocin treatment. These data will fill a key gap in our understanding of oxytocin's role in ASD and its ability to alter epigenetic modifications of the OXTR. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorders
• Autistic Disorder

• NCT number: NCT01944046
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2014
• Completion date: November 30, 2017