Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2015-06-30
2018-05-04
Brief Summary
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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.
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OCYTOCINA - SPRAY NASAL
OCYTOCINA - SPRAY NASAL - 24Ui twice per day for 8 weeks
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
Placebo
Placebo - twice per day for 8 weeks
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* presence of genetic and neurological syndromes
* changes in drugs or in any intervention during the study
12 Years
18 Years
MALE
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Helena Paula Brentani
Helena Paula Brentani
Principal Investigators
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Helena P. Brentani, PHD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo General Hospital
Locations
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Institute os Psychiatry, Clinical Hospital at São Paulo
São Paulo, , Brazil
Countries
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References
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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.
Other Identifiers
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CAAE 10922213.7.0000.0068
Identifier Type: -
Identifier Source: org_study_id
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