Clinical trial NCT01417026: Intranasal Oxytocin and Learning in Autism
Official title: Promoting Social Perceptual Learning With Oxytocin in Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorders
Keywords: Autism Spectrum Disorders
Oxytocin
Clinical Trial
Computer-based Intervention
Social Perception
Social Motivation
Social Cognition
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 36
Sex: MALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Recognizing faces is critical to social functioning, and can be improved for individuals with ASD by using intervention software in the form of appropriately designed computer games. The effects of this type of social intervention may be amplified with the concurrent use of oxytocin. Furthermore, these learning effects may impact social skills in general and translate to the level of the individual's everyday social behavior. Thus, the objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with 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.

Primary outcomes:
measure: Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery)
timeFrame: Baseline and Post-testing (after max. 12 days)
measure: Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version)
timeFrame: Baseline and Post-testing (after max. 12 days)
Secondary outcomes:
measure: Changes From Baseline to Post-testing (After Max. 12 Days) on the "Happy Faces" Measure of Social Attention
timeFrame: Baseline and Post-testing (after max. 12 days)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Center for Autism Research, The Children's Hospital of Philadelphia
name: Robert T. Schultz, PhD
role: PRINCIPAL_INVESTIGATOR
References: