Intranasal Oxytocin and Learning in Autism

• Status: Withdrawn
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

: The objective of this study is to determine the tolerability and therapeutic potential of oxytocin in children and adolescents with Autism Spectrum Disorders (ASD) when paired with a computer game intervention that is designed to enhance face perception skills. We designate two measures as our primary outcomes, based on prior published work with these interventions, and we propose a sample based on power analyses from these prior results. A second objective of this study is to learn about the breadth of possible positive effects that this combination therapy might have for children with ASD. To this end, we include a host of other exploratory measures that assess aspects of social motivation and attention, social perception, and social cognition. Thus, a second objective is to conduct a "signal finding" study - to gather outcome data on a range of dependent variables that theoretically should be related to oxytocin's effects on social processes, but for which there are no prior data. The signal finding aspect of this study will provide the preliminary data needed to design a more targeted follow up study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: Children's Hospital of Philadelphia
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

1. Subjects aged 12-17 years, Mental age ≥ 7 (as measured by an IQ test such as the Differential Ability Scales II).

2. Gender: males

3. Diagnosis of an ASD

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

6. Study participant needs to be on 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 acquired neurological abnormality affecting brain function and motor, sensory or higher cognitive functioning.

2. Patients with one or more of the following: HIV, HBV, 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., 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/P.I. (Suma Jacob, M.D,) that the patient is not suitable for the study due to unforeseeable safety issues.