Autism Oxytocin Brain Project

What Was Tested

The trial (phase 2) is built around Oxytocin.

The main goal of the study is to look at the effects of intranasal oxytocin on the brain in Autism Spectrum Disorder (ASD).

Oxytocin is a hormone that exists naturally in the body and the brain, affecting a wide range of social behaviors and emotions.

It had two arms (groups): Autism Spectrum Disorder (ASD) (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Nevertheless, there is still a need of determining target engagement for oxytocin's action on brain and behavior.

The aims of the research are to: 1.

Both participants and the experimenter will be blind to the type of the treatment administered.

The experimenter will be aware that the subject is receiving placebo.

Who Took Part

Enrollment: 51 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Have an ASD diagnosis based on the Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview (ADI) criteria, gold standards of research-based autism diagnosis. Intelligence quotient (IQ) \> 70. Normal or corrected-to-normal vision.

The full record lists 3 inclusion and 29 exclusion criteria; among the exclusions: recent occurrence of seizures (past 5 years); color blind; cardiovascular disease.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2017-05-10 with completion listed for 2018-10-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Resting State Functional Connectivity (rsFC) Salience Network (Anterior Cingulate Cortex (ACC) and Insula Versus Visual Cortex) (time frame: Post Intervention (Up to 40 minutes after receiving spray) at Study Visits 1, 2, 3 and 4). Blood Oxygen Level Dependent (BOLD) Activity in Response to Social Cues (time frame: Post Intervention (Up to 70 minutes) at Study Visits 1, 2, 3, and 4). Percent Change in Blood Oxygen Level Dependent (BOLD) Activity During Ball-Game Task (time frame: Post Intervention (up to 70 minutes) at Study Visits 1, 2, 3, and 4).

It also tracked 3 secondary outcomes, for example Rate of Smiling During Global Clinical Interview, Milliseconds of Visual Fixation and Social Learning Test (SLT) Reaction Time.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 51 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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