- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02007447
Oxytocin in Adolescents With Autism Spectrum Disorders (OXYASD)
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
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
São Paulo, Brazil, 05043-903
- Institute os Psychiatry, Clinical Hospital at São Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: OCYTOCINA - SPRAY NASAL
OCYTOCINA - SPRAY NASAL - 24Ui twice per day for 8 weeks
|
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:
|
Placebo Comparator: Placebo
Placebo - twice per day for 8 weeks
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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
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
Investigators
- Principal Investigator: Helena P. Brentani, PHD, University of Sao Paulo General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE 10922213.7.0000.0068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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