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Oxytocin in Spectrum Autism Disorders

Oxytocin in Individuals With Spectrum Autism Disorders

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03183674
Acronym
OxytocinASD
Enrollment
80
Registered
2017-06-12
Start date
2016-07-15
Completion date
2018-05-15
Last updated
2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autistic Disorder

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.

Interventions

DRUGOxytocin

Single dose oxytocin 45 minutes before the test

OTHERplacebo

saline solution 0,9% spray nasal

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 16 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Eye trackingon average of 1 yearEye tracking program

Secondary

MeasureTime frameDescription
Nepsyon average of 1 yearface recognize

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026