NCT02007447

Oxytocin in Adolescents With Autism Spectrum Disorders

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: Male
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-08-01
• Completion: 2018-05-04
• First posted: 2013-12-10
• Last updated: 2019-10-28

Locations

1 site across 1 country: Brazil