A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
Condition: Autism Spectrum Disorder; Pervasive Developmental Disorder; ASD; PDD
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Developmental Disabilities
Intervention: Intranasal Oxytocin
Intervention description: This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).
Intervention MeSH terms: Oxytocin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 12 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Autism Spectrum Disorders; Pervasive Developmental Disorder; ASD; PDD; Oxytocin; Syntocinon; Social Impairment; Treatment

Summary:

      This study is an 8-week pilot trial with oxytocin nasal spray (Syntocinon) as a treatment for
      social impairment in children and adults with high functioning autism spectrum disorders
      (ASD). The investigators hypothesize that oxytocin will be safe, tolerable, and effective in
      improving social deficits in individuals with ASD.
    

Eligibility criteria:

        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.