Oxytocin in Adolescents With Autism Spectrum Disorders
Overview
- Phase
- Phase 2
- Intervention
- OCYTOCINA - SPRAY NASAL
- Conditions
- Autism Spectrum Disorder
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- SOCIAL SKILLS
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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: 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)
Investigators
Helena Paula Brentani
Helena Paula Brentani
University of Sao Paulo General Hospital
Eligibility Criteria
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
Arms & Interventions
OCYTOCINA - SPRAY NASAL
OCYTOCINA - SPRAY NASAL - 24Ui twice per day for 8 weeks
Intervention: OCYTOCINA - SPRAY NASAL
Placebo
Placebo - twice per day for 8 weeks
Intervention: OCYTOCINA - SPRAY NASAL
Outcomes
Primary Outcomes
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 Outcomes
- REPETITIVE BEHAVIOR(8 WEEKS)