Oxytocin in Adolescents With Autism Spectrum Disorders (OXYASD)

October 24, 2019 updated by: Helena Paula Brentani, University of Sao Paulo General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Individuals with ASD have impaired social interaction, repetitive and disruptive behaviors. Oxytocin has been described to improve those skills and studies suggest that administration can reduce repetitive behaviors as well as enhance social interaction and communication deficits.

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.

Instruments:

  1. 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.
  2. 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.
  3. Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior
  4. Multidimensional Student's Life Satisfaction Scale (MSLSS)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05043-903
        • Institute os Psychiatry, Clinical Hospital at São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: OCYTOCINA - SPRAY NASAL
OCYTOCINA - SPRAY NASAL - 24Ui twice per day for 8 weeks
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
Other Names:
  • SYNTOCINON - SPRAY NASAL
  • OXYTOCIN
Placebo Comparator: Placebo
Placebo - twice per day for 8 weeks
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
Other Names:
  • SYNTOCINON - SPRAY NASAL
  • OXYTOCIN

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SOCIAL SKILLS
Time Frame: 8 weeks
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.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
REPETITIVE BEHAVIOR
Time Frame: 8 WEEKS
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.
8 WEEKS

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior
Time Frame: 8 WEEKS
Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior
8 WEEKS
Multidimensional Student's Life Satisfaction Scale (MSLSS)
Time Frame: 8 WEEKS
Multidimensional Student's Life Satisfaction Scale (MSLSS): SCALE OF QUALITY OF LIFE
8 WEEKS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Helena P. Brentani, PHD, University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAAE 10922213.7.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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