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Oxytocin in Adolescents With Autism Spectrum Disorders

NCT02007447 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-10-28

No results posted yet for this study

Summary

This study is design to evaluate the influence of oxytocin in some aspects of Autism Spectrum Disorder (ASD), such as, repetitive and stereotyped behavior, social skills, quality of life and disruptive behaviors.

Null hypothesis: social skills, quality of life, disruptive behaviors and repetitive behaviors do not improve with the use of oxytocin. Experimental Hypothesis: social skills, quality of life, disruptive behaviors and repetitive and stereotyped behaviors improve with the use of oxytocin.

Conditions

Interventions

DRUG

OCYTOCINA - SPRAY NASAL

The initial sample is divided into two groups (A and B): group A receive oxytocin intranasal for 8 weeks 24UI twice a day (3 applications per nostril 4UI 12/12 hours); group B will receive placebo for 8 weeks

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Helena P. Brentani, PHD · University of Sao Paulo General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-08-31
Completion
2018-05-04

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02007447 on ClinicalTrials.gov