search
Back to results

Oxytocin in Spectrum Autism Disorders (OxytocinASD)

Primary Purpose

Autistic Disorder

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Oxytocin
placebo
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autistic Disorder

Eligibility Criteria

3 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Instituto de Psiquiatria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

oxytocin spray

placebo

Arm Description

oxytocin nose spray dose 0,4IU/kg, once unique dose

saline nose spray, 0,9 %, once unique dose

Outcomes

Primary Outcome Measures

Eye tracking
Eye tracking program

Secondary Outcome Measures

Nepsy
face recognize

Full Information

First Posted
May 23, 2017
Last Updated
October 24, 2019
Sponsor
University of Sao Paulo General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03183674
Brief Title
Oxytocin in Spectrum Autism Disorders
Acronym
OxytocinASD
Official Title
Oxytocin in Individuals With Spectrum Autism Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 15, 2016 (Actual)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
May 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oxytocin spray
Arm Type
Experimental
Arm Description
oxytocin nose spray dose 0,4IU/kg, once unique dose
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
saline nose spray, 0,9 %, once unique dose
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
syntocinon
Intervention Description
Single dose oxytocin 45 minutes before the test
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
saline solution 0,9% spray nasal
Primary Outcome Measure Information:
Title
Eye tracking
Description
Eye tracking program
Time Frame
on average of 1 year
Secondary Outcome Measure Information:
Title
Nepsy
Description
face recognize
Time Frame
on average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debora Zambori
Organizational Affiliation
Instituto de Psiquiatria
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto de Psiquiatria
City
São Paulo
ZIP/Postal Code
04117-130
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Oxytocin in Spectrum Autism Disorders

We'll reach out to this number within 24 hrs