Oxytocin in Adolescents With Autism Spectrum Disorders (OXYASD)
Primary Purpose
Autism Spectrum Disorder
Status
Terminated
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
OCYTOCINA - SPRAY NASAL
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring autism, oxytocin, autism spectrum disorder, social skills.
Eligibility 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
Sites / Locations
- Institute os Psychiatry, Clinical Hospital at São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
OCYTOCINA - SPRAY NASAL
Placebo
Arm Description
OCYTOCINA - SPRAY NASAL - 24Ui twice per day for 8 weeks
Placebo - twice per day for 8 weeks
Outcomes
Primary Outcome Measures
SOCIAL SKILLS
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
REPETITIVE BEHAVIOR
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.
Full Information
NCT ID
NCT02007447
First Posted
December 5, 2013
Last Updated
October 24, 2019
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02007447
Brief Title
Oxytocin in Adolescents With Autism Spectrum Disorders
Acronym
OXYASD
Official Title
Oxytocin in Adolescents With Autism Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Most of our patients had no willingness to participate in the survey
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
May 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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:
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.
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.
Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior
Multidimensional Student's Life Satisfaction Scale (MSLSS)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
autism, oxytocin, autism spectrum disorder, social skills.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCYTOCINA - SPRAY NASAL
Arm Type
Active Comparator
Arm Description
OCYTOCINA - SPRAY NASAL - 24Ui twice per day for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo - twice per day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
OCYTOCINA - SPRAY NASAL
Other Intervention Name(s)
SYNTOCINON - SPRAY NASAL, OXYTOCIN
Intervention Description
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
Primary Outcome Measure Information:
Title
SOCIAL SKILLS
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
REPETITIVE BEHAVIOR
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.
Time Frame
8 WEEKS
Other Pre-specified Outcome Measures:
Title
Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior
Description
Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior
Time Frame
8 WEEKS
Title
Multidimensional Student's Life Satisfaction Scale (MSLSS)
Description
Multidimensional Student's Life Satisfaction Scale (MSLSS): SCALE OF QUALITY OF LIFE
Time Frame
8 WEEKS
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena P. Brentani, PHD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute os Psychiatry, Clinical Hospital at São Paulo
City
São Paulo
ZIP/Postal Code
05043-903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23480321
Citation
Tachibana M, Kagitani-Shimono K, Mohri I, Yamamoto T, Sanefuji W, Nakamura A, Oishi M, Kimura T, Onaka T, Ozono K, Taniike M. Long-term administration of intranasal oxytocin is a safe and promising therapy for early adolescent boys with autism spectrum disorders. J Child Adolesc Psychopharmacol. 2013 Mar;23(2):123-7. doi: 10.1089/cap.2012.0048. Epub 2013 Mar 12.
Results Reference
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Oxytocin in Adolescents With Autism Spectrum Disorders
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