Trial Search Results

Intranasal Oxytocin Treatment for Social Deficits in Children With Autism

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Drug: Oxytocin nasal spray
  • Drug: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - 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:

   - 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.

Ages Eligible for Study

6 Years - 12 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

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