drugset / Trial / NCT01624194

Intranasal Oxytocin Treatment for Social Deficits in Children With Autism

NCT01624194

Phase 2 Completed 54 enrolled Stanford University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication, and the presence of repetitive or stereotyped behaviors. It is one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88 children in the United States. At present, pharmacotherapies target only associated features of autism, with no effective drug treatments for the social impairments. Several lines of evidence now suggest that the neuropeptide oxytocin (OT) may be an effective treatment for the core social deficits in autism. Here we will test the effects of twice daily intranasal OT (24 IU) over a 4-week period for enhancing social deficits in male and female children aged 6-12 years with autism. This research has high potential to lead to the development of more effective treatments and earlier interventions for children with autism.

Timeline

Start
2012-06
Primary completion
2016-05
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oxytocin Peptide 24 iu Intranasal

Indications