Overview

This trial is active, not recruiting.

Condition autism spectrum disorder
Treatment ocytocina - spray nasal
Phase phase 2/phase 3
Sponsor University of Sao Paulo General Hospital
Start date November 2013
End date July 2014
Trial size 30 participants
Trial identifier NCT02007447, CAAE 10922213.7.0000.0068

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
OCYTOCINA - SPRAY NASAL - 24Ui twice per day for 8 weeks
ocytocina - spray nasal SYNTOCINON - 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
(Placebo Comparator)
Placebo - twice per day for 8 weeks

Primary Outcomes

Measure
SOCIAL SKILLS
time frame: 8 weeks

Secondary Outcomes

Measure
REPETITIVE BEHAVIOR
time frame: 8 WEEKS

Eligibility Criteria

Male participants from 12 years up to 18 years old.

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

Additional Information

Official title Oxytocin in Adolescents With Autism Spectrum Disorders
Principal investigator Helena P. Brentani, PHD
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)
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.