Oxytocin in Spectrum Autism Disorders
- Registration Number
- NCT03183674
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description placebo placebo saline nose spray, 0,9 %, once unique dose oxytocin spray Oxytocin oxytocin nose spray dose 0,4IU/kg, once unique dose
- Primary Outcome Measures
Name Time Method Eye tracking on average of 1 year Eye tracking program
- Secondary Outcome Measures
Name Time Method Nepsy on average of 1 year face recognize
Trial Locations
- Locations (1)
Instituto de Psiquiatria
🇧🇷São Paulo, Brazil