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.