Oxytocin in Spectrum Autism Disorders

NCT ID: NCT03183674

Last Updated: 2019-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-15

Study Completion Date

2018-05-15

Brief Summary

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Observe effects of oxytocin on individuals with autism spectrum disorder

Detailed Description

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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.

Conditions

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Autistic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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oxytocin spray

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

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Single dose oxytocin 45 minutes before the test

placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

saline solution 0,9% spray nasal

Interventions

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Oxytocin

Single dose oxytocin 45 minutes before the test

Intervention Type DRUG

placebo

saline solution 0,9% spray nasal

Intervention Type OTHER

Other Intervention Names

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syntocinon

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Helena Paula Brentani

Prof. DRa

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Debora Zambori

Role: STUDY_CHAIR

Instituto de Psiquiatria

Locations

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Instituto de Psiquiatria

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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10922213.7.0000.0068-2

Identifier Type: -

Identifier Source: org_study_id

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