Oxytocin in Adolescents With Autism Spectrum Disorders

What Was Tested

This registered phase 2, phase 3 trial tested Oxytocin.

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.

It had two arms (groups): OCYTOCINA - SPRAY NASAL (active comparator) and Placebo (placebo comparator).

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

Placebo - twice per day for 8 weeks.

The registry classes the interventions as drug.

More on the Plan

Individuals with ASD have impaired social interaction, repetitive and disruptive behaviors.

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.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to men only aged from 12 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age between 11 years 11 months and 17 years 11 months. Autism spectrum disorder according to DSM V. ADI \> 10. WISC \> 70. CARS \> 30.

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: presence of genetic and neurological syndromes; changes in drugs or in any intervention during the study.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-06 with completion listed for 2015-08.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: SOCIAL SKILLS (time frame: 8 weeks).

It also tracked 1 secondary outcome, for example REPETITIVE BEHAVIOR.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Oxytocin in 30 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.