Brain Imaging of Intranasal Oxytocin Treatment in Autism

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 4 part study:

Phase 1a. -functional magnetic resonance imaging (fMRI) ( with oxytocin 24 IU vs. placebo = oxytocin 0 IU) - funded by grant #U54 HD079124-01, Phase 1b-eye-tracking(oxytocin 24 IU vs. placebo = oxytocin 0 IU), Phase 2a. fMRI (oxytocin 8 IU vs. oxytocin 40IU), Phase 2b. -eye-tracking (oxytocin 8IU vs. oxytocin 40IU). Time course of effect will also be assessed within session.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Duke University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• Between 6 and 18 years of age, inclusive

• Have a clinical diagnosis of an autism spectrum disorder confirmed according to the Autism Diagnostic Observation Scale (ADOS, Lord et al., 1989). Diagnosis may also be confirmed using the Autism Diagnostic Interview-Revised (ADI-R).

• Male or female of any race or ethnicity

• Ambulatory status (outpatient) at time of assent/consent

• Estimated IQ greater than or equal to 70 and capable of making an informed decision based on assessment of their understanding and judgment

Exclusion Criteria:

• History of neurological injury: head trauma, poorly-controlled seizure disorder (i.e. seizure within the preceding six month period), stroke, prior neurosurgery, or under the care of a neurologist or neurosurgeon as determined by interview

• History of claustrophobia

• Implanted medical devices, implanted metal debris, shrapnel, certain tattoos, or permanent makeup that is contraindicated for MRI. Participants fill out a detailed questionnaire on the day of scanning to identify potential MRI risks

• Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. This includes, but is not limited to: Rett Syndrome, impairment of renal function, evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder or uncontrolled hypertension), respiratory, hepatic, or gastrointestinal disease

• Marked sensory impairment such as deafness or blindness that would interfere with the conduct of the study

• Pregnant or nursing because of the unknown effects of oxytocin to unborn babies and/or nursing infants. All females of child-bearing potential will be administered a serum pregnancy test at screening and at any point during the study at physician discretion. Refusal to undergo a pregnancy test will result in exclusion from the study. We will share results of a pregnancy test with the subject's legal guardian.

• Refusal to do pregnancy testing with understanding that guardian will be informed of positive test results

• Inability or refusal of sexually active female subjects (who have begun menses) to utilize two medically accepted barrier forms of birth control

• Use of hormonal birth control

• Subjects who have a history of an anaphylactic reaction from prior treatment with oxytocin (nasal spray)

• Inability of caretakers to speak English

• Absence of a consistent caretaker to report on symptoms

• Subjects who, in the Investigator's opinion, might not be suitable for the study