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Oxytocin in Adolescents With Autism Spectrum Disorders (OXYASD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02007447
Recruitment Status : Terminated (Most of our patients had no willingness to participate in the survey)
First Posted : December 10, 2013
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Helena Paula Brentani, University of Sao Paulo General Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: OCYTOCINA - SPRAY NASAL Phase 2 Phase 3

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxytocin in Adolescents With Autism Spectrum Disorders
Study Start Date : June 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : May 4, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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

  2. Multidimensional Student's Life Satisfaction Scale (MSLSS) [ Time Frame: 8 WEEKS ]
    Multidimensional Student's Life Satisfaction Scale (MSLSS): SCALE OF QUALITY OF LIFE



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007447


Locations
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Brazil
Institute os Psychiatry, Clinical Hospital at São Paulo
São Paulo, Brazil, 05043-903
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Helena P. Brentani, PHD University of Sao Paulo General Hospital

Publications:
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Responsible Party: Helena Paula Brentani, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02007447    
Other Study ID Numbers: CAAE 10922213.7.0000.0068
First Posted: December 10, 2013    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Helena Paula Brentani, University of Sao Paulo General Hospital:
autism, oxytocin, autism spectrum disorder, social skills.
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Pathologic Processes
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs