Trial · Interventional

TerminatedPhase 2/3Registry data

Oxytocin in Adolescents With Autism Spectrum Disorders

Short name OXYASD

NCTNCT02007447Other idCAAE 10922213.7.0000.0068

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Most of our patients had no willingness to participate in the survey

Overview

Status: Terminated
Phase: Phase 2/3
Enrollment: 30 participants (actual)
Sponsor: University of Sao Paulo General Hospital · Other
Design: Randomized · Quadruple masking
Countries: 1 country
Brazil
Start: Jun 2015
Primary completion: Aug 2015
Completion: 4 May 2018
First posted: 10 Dec 2013 (estimated)
Last update posted: 28 Oct 2019
Conditions: Autism Spectrum Disorder

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20152016201720182019

Ph 2/3
OXYASD
NCT02007447
Jun 2015 to 4 May 2018
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

OCYTOCINA - SPRAY NASALDrug

Arms2

Active comparator
OCYTOCINA - SPRAY NASAL
OCYTOCINA - SPRAY NASAL - 24Ui twice per day for 8 weeks
Placebo comparator
Placebo
Placebo - twice per day for 8 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

SOCIAL SKILLS
Time frame · 8 weeks
Registry description
Evaluation of social skills: Matson Evaluation of Social Skills (MESSY): consisting of 62 items divided into six factors that assess social skills such as appropriate social skills, assertiveness inadequate, impulsivity, self-confidence, jealousy withdraw, and other items that do not fit another classification.

Secondary outcomes(1)

REPETITIVE BEHAVIOR
Time frame · 8 WEEKS
Registry description
Evaluation of repetitive behavior: Repetitive Behavior Scale (RBS): Consists of 43 items divided into six subscales: stereotyped behavior, self-harm behavior, compulsive behavior, ritualistic behavior, behavior monotonous and restricted behavior. This scale is able to measure the presence and severity of repetitive behaviors as common in individuals on the autism spectrum.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2013

6 results

Long-term administration of intranasal oxytocin is a safe and promising therapy for early adolescent boys with autism spectrum disorders.

Tachibana et al. 2013Journal of child and adolescent psychopharmacologycited by 120

PMID 23480321DOI 10.1089/cap.2012.0048PUB-23480321

Full text at the publisher6 results

Publisher page See results (6)

Eligibility

Who could join, as posted.

Sex: Male
Age: from 12 Years up to 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Male * Age between 11 years 11 months and 17 years 11 months * Autism spectrum disorder according to DSM V * ADI \> 10 * WISC \> 70 * CARS \> 30 Exclusion Criteria: * Female * presence of genetic and neurological syndromes * changes in drugs or in any intervention during the study

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