Intranasal Oxytocin and Learning in Autism
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Intervention: Intranasal Oxytocin (Trade name: Syntocinon)
Intervention description: This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period.
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: Male
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Autism Spectrum Disorders; Oxytocin; Clinical Trial; Computer-based Intervention; Social Perception; Social Motivation; Social Cognition

Summary:

      The main objective of this study is to determine the safety and therapeutic potential of
      intranasal oxytocin in children and adolescents with autism spectrum disorder (ASD) when
      paired with a computer game intervention that is designed to enhance face perception skills.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants aged 12-17 years, Mental age ≥ 10

          2. Gender: males

          3. Diagnosis of an Autism Spectrum Disorder

          4. Consent: parent/guardian permission and child assent.

          5. Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and
             fluency in English (and English as a first language).

          6. Study participant needs to be clinically stable, in the opinion of the study
             clinicians. Stability will be assessed by the clinicians based on information from and
             conversations with the parent, if necessary. The parent needs to commit verbally to
             not making any changes to his or her child's current treatments for the duration of
             this study.

        Exclusion Criteria:

          1. History of traumatic brain injury, epilepsy/seizure disorder (except febrile
             seizures), or other significant medical, genetic, or neurological abnormality
             affecting growth, development, or motor or higher cortical functioning. Sensory
             impairments (e.g., significant vision/hearing loss).

          2. Patients with one or more of the following: Human immunodeficiency virus (HIV),
             Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), hemophilia (bleeding problems,
             recent nose and brain injuries), abnormal blood pressure (hypotension or
             hypertension), drug abuse, immunity disorder, or severe depression.

          3. Sensory impairments (e.g., significant vision/hearing loss).

          4. Gestational age below 35 weeks and/or perinatal injury.

          5. Profound mental retardation (e.g., Intelligence quotient (IQ) < 45) or sensory-motor
             difficulties that would preclude valid use of diagnostic instruments.

          6. Lack of impairment in face recognition as determined by average or above average
             performance on the Benton Face Recognition Task.

          7. Female participants.

          8. Patients who are sensitive to Syntocinon or any components of its formulation.

          9. Fever at the time of the baseline visit, defined as temperature above 37.5 degrees
             Celsius or 99.5 degrees Fahrenheit.

         10. Judgment by the study physician or the PI that the patient is not suitable for the
             study due to unforeseeable safety issues.