Intranasal Oxytocin Treatment for Social Deficits in Children With Autism

Completed · Phase 2 · Has a placebo group

Conditions studied: Autism

In brief

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.

Key facts

Study ID

NCT01624194

Run by

Stanford University

People needed

54

Starts

2012-06-01

Expected to finish

2016-05-01

Last updated by the study team

2019-07-15

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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