Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Adults With Autism Spectrum Disorder

What Was Tested

This registered phase 1, phase 2 trial tested Oxytocin.

Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate lactation in breastfeeding women.

The intranasal administration of OT has recently attracted attention as a potential novel treatment in several psychiatric disorders in autism.

However, given the anatomy of the nasal cavity, the current design of nasal sprays would be expected to provide an inadequate delivery of medication to the areas of the nasal cavity where direct transport into the brain via the olfactory nerve could potentially occur.

It had three arms (groups): one (active comparator), one (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as device and drug.

Who Took Part

Enrollment: 17 actual participants took part.

It was open to men only aged from 18 years up to 35 years.

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

Examples of who could join: Male subjects between the ages of 18 and 35, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis. Subjects must be in good general health, as determined by the investigator. Subjects must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information. Provision of a signed, written informed consent.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: subjects with evidence of previous nasal disease, surgery, and dependence on inhaled drugs; psychiatric co-morbidity that requires intervention (e.g., psychosis spectrum disorders, suicide intent); systemic illness requiring treatment within 2 weeks prior to study day 1.

How the Study Was Run

The set-up was randomized, crossover and triple-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.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2015-04 with completion listed for 2016-02.

It ran at 1 site in Norway.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Performance on an emotion sensitivity test (time frame: 45 mins after oxytocin/placebo administration). Performance on a facial emotion morphing task (time frame: 45 mins after oxytocin/placebo administration).

It also tracked 4 secondary outcomes, for example Performance on the reading the mind in the eyes test, Performance on an emotional dot probe task, Heart rate variability and Eyetracking.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Oxytocin in 17 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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