Dose Response Relationship of Oxytocin on Irritability in Youths

What Was Tested

This registered phase 1, phase 2 trial tested Oxytocin.

Planned enrollment is 80 subjects over 3 years.

It had five arms (groups): Intranasal Spray Placebo (placebo comparator), one (active comparator), one (active comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as drug and procedure.

More on the Plan

Endogenous oxytocin (OXT) has been a focus of prior psychiatric research due to its role in pro-social behavior, and modulation of response to social/emotional stimuli.

Although many studies argue that the intranasal administration of OXT can produce behavioral as well as neural changes, there is surprisingly little comprehensive research on this issue.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 14 years up to 18 years.

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

Examples of who could join: 14-18 years of age.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: past history of allergic reaction to oxt and its intranasal product; history of central nervous system (cns) disease (including history of seizure, epilepsy, cns tumor, cns hemorrhage, or serious cns infection including meningitis or encephalitis); A positive urine pregnancy test.

How the Study Was Run

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

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 and investigator.

It started in 2022-02-18 with completion listed for 2024-02-27.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Blood Oxygen Level Dependent (BOLD) response within rostro-medial prefrontal cortex ( rmPFC) region of interest to emotional stimuli during the Affective Stroop (AS) at approximately 50 minutes after intranasal administration of OXT (time frame: 50 minutes). Plasma concentrations of OXT at 10, 20, 30, 40, and 50 minutes post intranasal OXT administration, and immediately post-fMRI scanning (time frame: 50 minutes and 2 hours).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Oxytocin in 60 people.

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.