Status:
COMPLETED
Intranasal Oxytocin and Learning in Autism
Lead Sponsor:
Robert Schultz
Conditions:
Autism Spectrum Disorders
Eligibility:
MALE
12-17 years
Phase:
PHASE2
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...
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 th...
Eligibility Criteria
Inclusion
- Participants aged 12-17 years, Mental age ≥ 10
- Gender: males
- Diagnosis of an Autism Spectrum Disorder
- Consent: parent/guardian permission and child assent.
- Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English (and English as a first language).
- 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
- 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).
- 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.
- Sensory impairments (e.g., significant vision/hearing loss).
- Gestational age below 35 weeks and/or perinatal injury.
- Profound mental retardation (e.g., Intelligence quotient (IQ) \< 45) or sensory-motor difficulties that would preclude valid use of diagnostic instruments.
- Lack of impairment in face recognition as determined by average or above average performance on the Benton Face Recognition Task.
- Female participants.
- Patients who are sensitive to Syntocinon or any components of its formulation.
- Fever at the time of the baseline visit, defined as temperature above 37.5 degrees Celsius or 99.5 degrees Fahrenheit.
- Judgment by the study physician or the PI that the patient is not suitable for the study due to unforeseeable safety issues.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01417026
Start Date
September 1 2011
End Date
April 1 2015
Last Update
March 30 2017
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104