Oxytocin in Spectrum Autism Disorders

NCT03183674 — Phase 1, Completed, 80 participants, University of Sao Paulo General Hospital

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Oxytocin in Individuals With Spectrum Autism Disorders

Registry	NCT03183674, acronym OxytocinASD
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: quadruple, other
Enrollment	80 (Actual)
Sponsor	University of Sao Paulo General Hospital (Other)
Conditions	Autistic Disorder
Interventions	Oxytocin, placebo (Drug, other)
Dates	start 2016-07-15, primary completion 2017-07-20, completion 2018-05-15, first posted 2017-06-12, last updated 2019-10-28
Locations	1 site in Brazil

-Summary

Observe effects of oxytocin on individuals with autism spectrum disorder

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
oxytocin spray	Experimental	Drug: Oxytocin	oxytocin nose spray dose 0,4IU/kg, once unique dose
placebo	Placebo comparator	Other: placebo	saline nose spray, 0,9 %, once unique dose

Oxytocin (Drug), also known as syntocinon: Single dose oxytocin 45 minutes before the test
placebo (Other): saline solution 0,9% spray nasal

+Outcome measures

Primary outcomes

Eye tracking [on average of 1 year]: Eye tracking program

Secondary outcomes

Nepsy [on average of 1 year]: face recognize

+Eligibility

Sex: All, ages: 3 Years to 16 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Instituto de Psiquiatria	São Paulo	Brazil

+Investigators

Debora Zambori, Study chair, Instituto de Psiquiatria

My Notes

Public

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