Oxytocin in Individuals With Spectrum Autism Disorders
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Eye tracking
Study Overview
Brief Summary
Observe effects of oxytocin on individuals with autism spectrum disorder
Detailed Description
To observe the effects of oxytocin on individuals with autism spectrum disorder according to gender, in facial recognition and eye tracking tests. The investigators will apply the nepsy and eye tracking tests before and 45 minutes after the puff with oxytocin or placebo at the dose of 0.4 IU / kg / dose maximum of 24 IU. The next week the volunteer will return and will do the same procedure because whoever took the placebo would take oxytocin and vice versa. Is a randomized, double-blind, placebo-controlled clinical trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosis of ASD by DSMV
- •CARS> 30
- •age between 3 and 16 years
- •stable (3 months with medication maintained or without medication)
Exclusion Criteria
- •pregnant women, infants and
- •participation in another research project of pharmacological or behavioral intervention in progress
- •Use of pituitary hormones, cortisol, androgens and estrogens.
- •heart problems: recent AMI, heart failure.
- •respiratory problems: pneumonia, respiratory failure, decompensated asthma, acute bronchitis.
Arms & Interventions
oxytocin spray
oxytocin nose spray dose 0,4IU/kg, once unique dose
Intervention: Oxytocin (Drug)
placebo
saline nose spray, 0,9 %, once unique dose
Intervention: placebo (Other)
Outcomes
Primary Outcomes
Eye tracking
Time Frame: on average of 1 year
Eye tracking program
Secondary Outcomes
- Nepsy(on average of 1 year)
Investigators
Helena Paula Brentani
Prof. DRa
University of Sao Paulo General Hospital