A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder

Inclusion Criteria:

- Males and females between 12 and 55 years of age.

- Meets the DSM-5 diagnostic criteria for Autism Spectrum Disorder (ASD) as established
by clinical diagnostic interview

- At least moderate severity of ASD impairment as measured by a raw score of ≥85 on the
SRS

- Participants and their parent/guardian must be able to speak and understand English
sufficiently to comprehend the nature of the study and to allow for the completion of
all study procedures required per protocol.

- Subjects and their parent/guardian must be considered reliable reporters. They must
understand the nature of the study and must sign an IRB-approved informed consent form
before initiation of any study procedures. Subjects and their parent/guardian must
have a level of understanding sufficient to communicate with the investigator and
study coordinator, and to cooperate with all tests and examinations required by the
protocol.

- Each subject and their parent/guardian must understand the nature of the study and
provide written informed assent/consent.

- Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to
participate in the study provided they do not meet any exclusionary criteria.

- If the subject is sexually active, he/she must agree to use an acceptable form of
birth control during the study. These include:

- Abstinence (no sexual contact)

- A barrier method (diaphragm plus spermicide or a condom plus spermicide) in addition
to one of the following methods:

- Consistent use of an approved birth control pill

- Birth control patch

- Injected contraceptives

- Intrauterine device (IUD)

Exclusion Criteria:

- Impaired intellectual functioning and/or impaired spoken language.

- Clinically unstable psychiatric conditions or any serious medical illness, which will
be assessed by study clinicians during the psychiatric interview and medical history
review. If the clinical assessment suggests a psychiatric or medical condition
demanding acute clinical attention, then the subject will be excluded from
participating in the trial.

- Clinically unstable psychiatric conditions.

- Any serious medical illness

- Pregnant or nursing females.

- Known hypersensitivity to oxytocin.

- Severe allergies or multiple adverse drug reactions.

- A non-responder or history of intolerance to oxytocin, after treatment at adequate
doses as determined by the clinician.

- Subjects with significant nasal pathology (including atrophic rhinitis, recurrent nose
bleeds, and history of hypophysectomy).

- Clinically abnormal baseline laboratory values falling significantly outside of the
standard reference ranges for a basic metabolic screen.

- Investigator and his/her immediate family defined as the investigator's spouse,
parent, child, grandparent, or grandchild.

- Currently enrolled or recently participated (within the past 6 months) in a clinical
trial of intranasal oxytocin.