Intranasal Oxytocin Treatment for Social Deficits in Children With Autism

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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.

Eligibility Criteria

Ages Eligible for Study: 6 Years to 12 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Medically healthy outpatients between 6 and 12 years of age (cut off 12 years and 11 months) - 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:
  1. - 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 hemihydrate) - 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.


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
Karen J. Parker, PhD

Contact us to find out if this trial is right for you.


Robin Libove, BS
(650) 736-1235