NCT03183674

Brief Summary

Observe effects of oxytocin on individuals with autism spectrum disorder

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

May 23, 2017

Last Update Submit

October 24, 2019

Conditions

Autistic Disorder

Outcome Measures

Primary Outcomes (1)

  • Eye tracking

    Eye tracking program

    on average of 1 year

Secondary Outcomes (1)

  • Nepsy

    on average of 1 year

Study Arms (2)

oxytocin spray

EXPERIMENTAL

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

Drug: Oxytocin

placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

OxytocinDRUG

Single dose oxytocin 45 minutes before the test

Also known as: syntocinon
oxytocin spray
placeboOTHER

saline solution 0,9% spray nasal

placebo

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • CARS\> 30
  • age between 3 and 16 years
  • stable (3 months with medication maintained or without medication)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Psiquiatria

São Paulo, 04117-130, Brazil

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Debora Zambori

    Instituto de Psiquiatria

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. DRa

Study Record Dates

First Submitted

May 23, 2017

First Posted

June 12, 2017

Study Start

July 15, 2016

Primary Completion

July 20, 2017

Study Completion

May 15, 2018

Last Updated

October 28, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
6 months
Access Criteria
Clinicians and students

Locations

BR(1)