Trial | NCT03183674  Report issue

Title

Oxytocin in Spectrum Autism Disorders
Oxytocin in Individuals With Spectrum Autism Disorders

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    oxytocin ...

  • Study Participants

    80
Observe effects of oxytocin on individuals with autism spectrum disorder
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 Started
Jul 15
2016
Primary Completion
Jul 20
2017
Study Completion
May 15
2018
Last Update
Oct 28
2019

Drug Oxytocin

Single dose oxytocin 45 minutes before the test

  • Other names: syntocinon

Other placebo

saline solution 0,9% spray nasal

oxytocin spray Experimental

oxytocin nose spray dose 0,4IU/kg, once unique dose

placebo Placebo Comparator

saline nose spray, 0,9 %, once unique dose

Criteria 

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.
No Results Posted