Autism Oxytocin Brain Project

• Status: Completed
• Trial end date: 2018-10-03
• Target enrollment: 0
• Participant gender: Male

Summary

The main goal of the study is to look at the effects of intranasal oxytocin on the brain in Autism Spectrum Disorder (ASD). Oxytocin is a hormone that exists naturally in the body and the brain, affecting a wide range of social behaviors and emotions. The investigators will study the effects of different treatments (3 doses of oxytocin and one dose of placebo) on brain functional connectivity at rest in patients with ASD, using functional magnetic resonance imaging (fMRI). Investigators also seek to study how the effects of oxytocin treatment can be affected by genetic, immune and environmental factors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Oxytocin

Criteria

Inclusion Criteria for ASD Participants:

• Have an ASD diagnosis based on the Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview (ADI) criteria, gold standards of research-based autism diagnosis

• Intelligence quotient (IQ) > 70

• Normal or corrected-to-normal vision

Exclusion Criteria for ASD Participants:

• Recent occurrence of seizures (past 5 years)

• Brain damage or head trauma (can be included at discretion of PI and sponsor)

• Color blind

• Cardiovascular disease

• Presence of a severe medical problem

• Severe mental retardation

• Alcoholism or substance abuse

• Asthma (can be included at the discretion of study physician/nurse practitioner if episodes are infrequent and no active problems at time of the study)

• Migraine headaches (at the discretion of the nurse practitioner or the study physician)

• Claustrophobia (at discretion of study physician/designee/PI)

• Pacemakers, cochlear implants, surgical clips or metal fragments

Inclusion Criteria for Healthy Age-Matched Controls:

• IQ > 70

• Normal or corrected-to-normal vision

Exclusion Criteria for Healthy Age-Matched Controls:

• History of seizures

• Neurological disorder

• Current psychiatric disorder

• Previous psychiatric disorder (can be included at discretion of PI)

• Current use of psychoactive drugs

• Previous use of psychoactive drugs (can be included at discretion of PI)

• Head trauma (can be included at discretion of PI)

• Alcoholism or substance abuse

• Cardiovascular disease

• Color blind

• Asthma (can be included at the discretion of study physician/nurse practitioner if episodes are infrequent and no active problems at time of the study)

• Migraine headaches (at the discretion of the nurse practitioner or the study physician)

• Claustrophobia (at discretion of study physician/designee/PI)

• Presence of a severe medical problem

• Severe mental retardation

• Pacemakers, cochlear implants, surgical clips or metal fragments