An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders

Inclusion criteria

• Male and female outpatients ages 11-17 years
• DSM-IV-TR PDD diagnosis of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview and with the aid of the MGH ASD Symptom Checklist (MGH-ASD-SCL).
• At least moderate severity of ASD impairment as measured by a raw score of ≥80 on the SRS and a severity score of ≥4 on CGI-PDD.
• 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.
• Each subject and their parent/guardian must understand the nature of the study and provide written informed assent/consent.
• Subjects must be able to participate in mandatory blood draws.
• Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.

Exclusion criteria

• IQ <85
• Total lack of spoken language
• DSM-IV-TR PDD diagnosis of Rett's disorder or childhood disintegrative disorder.
• Clinically unstable psychiatric conditions or judged to be at serious suicidal risk as determined by evaluating investigator.
• History of substance use (except nicotine or caffeine) within past 3 months
• Serious, stable or unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
• Subjects with severe hepatic impairment (LFTs > 3 times ULN) and those with severely impaired renal function (eGFR < 30).
• 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).
• 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.