Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors

Completed · Phase 2 · Has a placebo group

Conditions studied: Autism Spectrum Disorders

In brief

The purpose of this research study is to learn about the effects of supplemental intranasal oxytocin as a treatment for improving social difficulties in children and adolescents with autism. This study will also provide additional information about the safety and tolerability of intranasal oxytocin. Investigators expect oxytocin will increase social motivation, improving daily living skills and quality of life.

Key facts

Study ID

NCT01944046

Run by

Linmarie Sikich

People needed

290

Starts

2014-08-01

Expected to finish

2017-11-30

Last updated by the study team

2021-06-18

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be between the ages of 3 years 0 months and 17 years 11 months at the time of randomization
• Be diagnosed by clinician experienced in assessment of ASD with autistic disorder, Asperger's syndrome, or PDD-NOS using DSM-V-TR criteria
• Must have clinical diagnosis of ASD confirmed using the Autism Diagnostic Observation Scale (ADOS, Lord et al., 2001)
• Must have clinical diagnosis of ASD confirmed using the Autism Diagnostic Interview-Revised (ADI-R, Rutter, 2003). ASD criteria proposed by Risi (2006). Specifically, subject must be within 1 point of autism criteria on both social and communication domains of the ADI or meet autism criteria in one of these ADI domains and come within 2 points of autism criteria in the other
• Have a guardian who is able to provide informed consent
• If cognitively able, subject must be able to provide informed assent/consent

You may not qualify if…

• Have a known diagnosis of Rett Syndrome or Childhood Disintegrative Disorder, or have marked sensory impairment such as deafness or blindness
• Have active cardiovascular disease or renal disease that is not controlled by medication
• Subjects who are pregnant, lactating, or who refuse to practice contraception if sexually active
• Subjects who have had changes in allied health therapies, behavioral or educational interventions within the two months prior to randomization other than those associated with school holidays
• Subjects who have had changes in psychiatric medications within 4 weeks of randomization
• Subjects who have had previous chronic treatment with oxytocin
• Subjects who have caretakers who are unable to speak English, be consistently present at visits to report on symptoms, or are otherwise judged as unable to comply with the protocol by the data collection site team
• Subjects with active seizures within the 6 months preceding screening or baseline -added part way through study in response to subject death.

Where it is running

• Lurie Center for Autism, Massachusetts General Hospital — Boston, Massachusetts, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Center for Autism and the Developing Brain — White Plains, New York, United States
• Duke Center for Autism and Brain Development — Durham, North Carolina, United States
• Duke University , Genetics Center — Durham, North Carolina, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Seattle Children's Hospital Research Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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