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OpenTrials
Completed

NCT Number: NCT03183674

Oxytocin in Spectrum Autism Disorders

Observe effects of oxytocin on individuals with autism spectrum disorder

Completed

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Key information

Conditions

Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Instituto de Psiquiatria

São Paulo, 04117-130, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxytocin

Drug

Single dose oxytocin 45 minutes before the test

Other names: syntocinon

Placebo

Other

saline solution 0,9% spray nasal

Primary outcomes

  1. Eye tracking

    Time frame: on average of 1 year

    Eye tracking program

Secondary outcomes

  1. Nepsy

    Time frame: on average of 1 year

    face recognize

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Oxytocin in Individuals With Spectrum Autism Disorders

Acronym: OxytocinASD

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jun 12, 2017
Registry last updated
Oct 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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