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Oxytocin 2013-09 ClinicalTrials

Intranasal Oxytocin Investigated for Social Cognition, Repetitive Behaviors in Pediatric ASD

Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders (ASD)

Background

Autism Spectrum Disorders (ASD) are neurodevelopmental conditions marked by significant challenges in social communication and the presence of restricted, repetitive behaviors. Current therapeutic approaches often struggle to effectively address these core social deficits. Previous research in adults with ASD has indicated that oxytocin administration can improve social cognition, reduce repetitive behaviors, and alleviate anxiety. Early findings also suggest similar potential benefits for children. This Phase 2 study aims to formally evaluate intranasal oxytocin as a targeted intervention for these critical symptoms in pediatric ASD.

Study Design

This was a Phase 2, randomized, quadruple-blind, placebo-controlled clinical trial (NCT01417026). A total of 36 children and adolescents diagnosed with Autism Spectrum Disorders (ASD) were enrolled. Participants were randomized to receive either 24 IU intranasal oxytocin (Syntocinon®) or a placebo. The intervention was administered daily for a 5-day period, alongside concomitant computer game play. The primary objective was to assess the efficacy of oxytocin in improving social cognition and reducing repetitive behaviors in this pediatric population.


Source: clinicaltrials:NCT01908205 · Ingested 2026-07-22 · Digest: gemini-2.5-flash