Intranasal Oxytocin in Youth With Autism

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

It had two arms (groups): Oxytocin (experimental) and Placebo (placebo comparator).

Placebo delivered with a pump-actuated nasal spray device, administered twice-daily.

The registry classes the interventions as drug.

Who Took Part

The registry lists 128 planned participants were the target.

It was open to people of any sex aged from 12 years up to 20 years.

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

Examples of who could join: Male and female participants between the ages of 12 and 20, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis as per the ADOS/ADI. Participants must be in good general physical health, as determined by the investigator.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: previous nasal disease, surgery, and dependence on inhaled drugs; systemic illness requiring treatment within 2 weeks prior to study day 1; full scale iq \< 70 (due to the prerequisite ability to complete self-report measures).

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

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

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

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 2024-09-18 with completion listed for 2025-11-04.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Social behavior (time frame: Four weeks). Repetitive behaviour (time frame: Four weeks).

It also tracked 4 secondary outcomes, for example Behavioral inflexibility, Social cognition, Repetitive cognition and Vagally-mediated heart rate variability.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 128 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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