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Oxytocin in Spectrum Autism Disorders (OxytocinASD)

U

University of Sao Paulo General Hospital

Status and phase

Completed
Phase 1

Conditions

Autistic Disorder

Treatments

Drug: Oxytocin
Other: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03183674
10922213.7.0000.0068-2

Details and patient eligibility

About

Observe effects of oxytocin on individuals with autism spectrum disorder

Full 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.

Enrollment

80 patients

Sex

All

Ages

3 to 16 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups, including a placebo group

oxytocin spray
Experimental group
Description:
oxytocin nose spray dose 0,4IU/kg, once unique dose
Treatment:
Drug: Oxytocin
placebo
Placebo Comparator group
Description:
saline nose spray, 0,9 %, once unique dose
Treatment:
Other: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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