At a glance
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Double-blind, Randomized, Placebo Controlled Trial of Intranasal Oxytocin Treatment for Social Deficits in Children With Autism.
In Brief
A Phase 2 clinical trial evaluating Oxytocin nasal spray and Placebo for Autism. Completed, enrolled 54 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice daily for 4-weeks.
3 x 0.1 mL sprays per nostril twice daily for 4-weeks.