Intranasal Oxytocin Treatment for Social Deficits in Children With Autism

Not Recruiting

Trial ID: NCT01624194,25503


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.

Official Title

Double-blind, Randomized, Placebo Controlled Trial of Intranasal Oxytocin Treatment for Social Deficits in Children With Autism.

Stanford Investigator(s)

Antonio Hardan, M.D.
Antonio Hardan, M.D.

Professor of Psychiatry and Behavioral Sciences

Kyle Hinman, M.D.
Kyle Hinman, M.D.

Clinical Assistant Professor, Psychiatry and Behavioral Sciences - Child & Adolescent Psychiatry and Child Development


Inclusion Criteria:

   - Medically healthy outpatients between 6 and 12 years of age (cut off 12 years and 11

   - Intelligence Quotient > 40

   - Diagnosis of autism spectrum disorder based on the Autism Diagnostic Interview -
   Revised, Autism Diagnostic Observation Schedule, and DSM-IV criteria

   - Clinical Global Impression severity rating of 4 or higher

   - Care provider who can reliably bring subject to clinic visits, provide trustworthy
   ratings, and interacts with the subject on a regular basis

   - Stable medications for at least 4 weeks

   - No planned changes in psychosocial interventions during the trial

   - Willingness to provide blood samples.

Exclusion Criteria:

   - Diagnostics and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis
   of schizophrenia, schizoaffective disorder, or psychotic disorder

   - Regular nasal obstruction or nosebleeds

   - Active medical problems: unstable seizures, significant physical illness (e.g.,
   serious liver, renal, or cardiac pathology)

   - Sensitivity to preservatives (in particular E 216, E 218, and chlorobutanol

   - A genetic abnormality (e.g., Fragile X Syndrome)

   - Significant hearing or vision impairments

   - Habitually drinks large volumes of water

   - Pregnancy, breastfeeding, or child birth within the last 6 months

   - Sexually active females not using a reliable method of contraception.


drug: Oxytocin nasal spray

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Robin Libove, BS
(650) 736-1235