Clinical trial NCT02007447: Oxytocin in Adolescents With Autism Spectrum Disorders
Official title: Oxytocin in Adolescents With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Autism Spectrum Disorder
Keywords: autism, oxytocin, autism spectrum disorder, social skills.
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 30
Sex: MALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: SOCIAL SKILLS
timeFrame: 8 weeks
Secondary outcomes:
measure: REPETITIVE BEHAVIOR
timeFrame: 8 WEEKS
Other outcomes:
measure: Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior
timeFrame: 8 WEEKS
measure: Multidimensional Student's Life Satisfaction Scale (MSLSS)
timeFrame: 8 WEEKS
Locations:
city: São Paulo
country: Brazil
facility: Institute os Psychiatry, Clinical Hospital at São Paulo
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Helena P. Brentani, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.