Oxytocin in Spectrum Autism Disorders

Autistic Disorder Clinical Trial

— OxytocinASD  

Official title:

Oxytocin in Individuals With Spectrum Autism Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183674
• Other study ID #: 10922213.7.0000.0068-2
• Status: Completed
• Phase: Phase 1
• Start date: July 15, 2016
• Est. completion date: May 15, 2018

Study information

• Verified date: October 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Observe effects of oxytocin on individuals with autism spectrum disorder

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 15, 2018
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autistic Disorder
• Disease

Intervention

Drug:
• Oxytocin
Single dose oxytocin 45 minutes before the test

Other:
• placebo
saline solution 0,9% spray nasal

Locations

Country	Name	City	State
Brazil	Instituto de Psiquiatria	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eye tracking	Eye tracking program	on average of 1 year
Secondary	Nepsy	face recognize	on average of 1 year