Oxytocin in Adolescents With Autism Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

— OXYASD  

Official title:

Oxytocin in Adolescents With Autism Spectrum Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02007447
• Other study ID #: CAAE 10922213.7.0000.0068
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: June 2015
• Est. completion date: May 4, 2018

Study information

• Verified date: October 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: May 4, 2018
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

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

Locations

Country	Name	City	State
Brazil	Institute os Psychiatry, Clinical Hospital at São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior	Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior	8 WEEKS
Other	Multidimensional Student's Life Satisfaction Scale (MSLSS)	Multidimensional Student's Life Satisfaction Scale (MSLSS): SCALE OF QUALITY OF LIFE	8 WEEKS
Primary	SOCIAL SKILLS	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	REPETITIVE BEHAVIOR	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