Intranasal Oxytocin and Learning in Autism

Recognizing faces is critical to social functioning, and can be improved for individuals
with ASD by using intervention software in the form of appropriately designed computer
games. The effects of this type of social intervention may be amplified with the concurrent
use of oxytocin. Furthermore, these learning effects may impact social skills in general and
translate to the level of the individual's everyday social behavior. Thus, the objective of
this study is to determine the safety and therapeutic potential of intranasal oxytocin in
children and adolescents with ASD when paired with a computer game intervention that is
designed to enhance face perception skills.

Inclusion Criteria:

1. Participants aged 12-17 years, Mental age ≥ 10

2. Gender: males

3. Diagnosis of an Autism Spectrum Disorder

4. Consent: parent/guardian permission and child assent.

5. Ability to complete tasks: adequate vision, motor control of a keyboard and mouse,
and fluency in English (and English as a first language).

6. Study participant needs to be clinically stable, in the opinion of the study
clinicians. Stability will be assessed by the clinicians based on information from
and conversations with the parent, if necessary. The parent needs to commit verbally
to not making any changes to his or her child's current treatments for the duration
of this study.

Exclusion Criteria:

1. History of traumatic brain injury, epilepsy/seizure disorder (except febrile
seizures), or other significant medical, genetic, or neurological abnormality
affecting growth, development, or motor or higher cortical functioning. Sensory
impairments (e.g., significant vision/hearing loss).

2. Patients with one or more of the following: Human immunodeficiency virus (HIV),
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), hemophilia (bleeding problems,
recent nose and brain injuries), abnormal blood pressure (hypotension or
hypertension), drug abuse, immunity disorder, or severe depression.

3. Sensory impairments (e.g., significant vision/hearing loss).

4. Gestational age below 35 weeks and/or perinatal injury.

5. Profound mental retardation (e.g., Intelligence quotient (IQ) < 45) or sensory-motor
difficulties that would preclude valid use of diagnostic instruments.

6. Lack of impairment in face recognition as determined by average or above average
performance on the Benton Face Recognition Task.

7. Female participants.

8. Patients who are sensitive to Syntocinon or any components of its formulation.

9. Fever at the time of the baseline visit, defined as temperature above 37.5 degrees
Celsius or 99.5 degrees Fahrenheit.

10. Judgment by the study physician or the PI that the patient is not suitable for the
study due to unforeseeable safety issues.