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) asestablished by clinical diagnostic interview

• At least moderate severity of ASD impairment as measured by a raw score of ≥85 onthe SRS

• Participants and their parent/guardian must be able to speak and understand Englishsufficiently to comprehend the nature of the study and to allow for the completionof all study procedures required per protocol.

• Subjects and their parent/guardian must be considered reliable reporters. They mustunderstand the nature of the study and must sign an IRB-approved informed consentform before initiation of any study procedures. Subjects and their parent/guardianmust have a level of understanding sufficient to communicate with the investigatorand study coordinator, and to cooperate with all tests and examinations required bythe protocol.

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

• Subjects with mood, anxiety, or disruptive behavior disorders will be allowed toparticipate 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 ofbirth control during the study. These include:

• Abstinence (no sexual contact)

• A barrier method (diaphragm plus spermicide or a condom plus spermicide) in additionto 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, whichwill be assessed by study clinicians during the psychiatric interview and medicalhistory review. If the clinical assessment suggests a psychiatric or medicalcondition demanding acute clinical attention, then the subject will be excluded fromparticipating 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 adequatedoses as determined by the clinician.

• Subjects with significant nasal pathology (including atrophic rhinitis, recurrentnose bleeds, and history of hypophysectomy).

• Clinically abnormal baseline laboratory values falling significantly outside of thestandard 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 clinicaltrial of intranasal oxytocin.