Clincosm LogoSign in Get a demo

OxytocinASD: Oxytocin in Spectrum Autism Disorders

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03183674
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
22
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Observe effects of oxytocin on individuals with autism spectrum disorder

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Oxytocin in Individuals With Spectrum Autism Disorders
Actual Study Start Date :
Jul 15, 2016
Actual Primary Completion Date :
Jul 20, 2017
Actual Study Completion Date :
May 15, 2018

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Eye tracking [on average of 1 year]

      Eye tracking program

    Secondary Outcome Measures

    1. Nepsy [on average of 1 year]

      face recognize

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto de Psiquiatria São Paulo Brazil 04117-130

    Sponsors and Collaborators

    • University of Sao Paulo General Hospital

    Investigators

    • Study Chair: Debora Zambori, Instituto de Psiquiatria

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helena Paula Brentani, Prof. DRa, University of Sao Paulo General Hospital
    ClinicalTrials.gov Identifier:
    NCT03183674
    Other Study ID Numbers:
    • 10922213.7.0000.0068-2
    First Posted:
    Jun 12, 2017
    Last Update Posted:
    Oct 28, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Autistic Disorder
    Oxytocin

    Study Results

    No Results Posted as of Oct 28, 2019