Oxytocin in Adolescents With Autism Spectrum Disorders (OXYASD)

University of Sao Paulo General Hospital

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Drug: OCYTOCINA - SPRAY NASAL

Study type: Interventional

Funder types: Other

Identifiers

NCT02007447

CAAE 10922213.7.0000.0068

Details and patient eligibility

About

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.

Full 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)

Enrollment: 30 patients

Sex: Male

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

OCYTOCINA - SPRAY NASAL

Active Comparator group

Description:

OCYTOCINA - SPRAY NASAL - 24Ui twice per day for 8 weeks

Treatment:

Drug: OCYTOCINA - SPRAY NASAL

Placebo

Placebo Comparator group

Description:

Placebo - twice per day for 8 weeks

Treatment:

Drug: OCYTOCINA - SPRAY NASAL