Oxytocin in Spectrum Autism Disorders (OxytocinASD)

October 24, 2019 updated by: Helena Paula Brentani, University of Sao Paulo General Hospital

Oxytocin in Individuals With Spectrum Autism Disorders

Observe effects of oxytocin on individuals with autism spectrum disorder

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04117-130
        • Instituto de Psiquiatria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: oxytocin spray
oxytocin nose spray dose 0,4IU/kg, once unique dose
Drug: Oxytocin
Single dose oxytocin 45 minutes before the test
Other Names:
  • syntocinon
Placebo Comparator: placebo
saline nose spray, 0,9 %, once unique dose
Other: placebo
saline solution 0,9% spray nasal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eye tracking
Time Frame: on average of 1 year
Eye tracking program
on average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nepsy
Time Frame: on average of 1 year
face recognize
on average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Study Chair: Debora Zambori, Instituto de Psiquiatria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2016

Primary Completion (Actual)

July 20, 2017

Study Completion (Actual)

May 15, 2018

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

June 9, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10922213.7.0000.0068-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators intend to share research information, such as, harms and benefits

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

Clinicians and students

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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