Oxytocin on Irritability/Emotional Dysregulation of Disruptive Behavior and Mood Disorders

What Was Tested

The trial (phase 2) is built around Oxytocin.

Irritability and emotional dysregulation are recognized as serious aspects of psychopathology seen in in pediatric psychiatric patients.

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

The registry classes the interventions as drug.

More on the Plan

The clinical interview includes past and current history of psychiatric symptoms/signs, past and current medical history, and past/current social/academic history.

Also the current medication (if any) and any medical condition that would have interaction with the psychiatric diagnosis will be reviewed.

The child/adolescent will receive the diagnosis of psychiatric syndrome at the end of the assessment sessions. 2.

Participants who respond to advertisement, after a phone screening session will be also invited. 3.

Who Took Part

Enrollment: 58 actual participants took part.

It was open to people of any sex aged from 10 years up to 18 years.

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

Examples of who could join: 10-18 years of age. A current diagnosis of ADHD, ODD, CD, or DMDD as determined by the Kiddie-SADS, lifetime version. If currently on medication, medication treatment must be stable for at least 6 weeks with a stimulant medication, alpha 2 agonist, atomoxetine or antidepressant.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: comorbid psychotic, tic, pervasive developmental, or substance abuse disorders; major medical illness that prohibits treatment by oxytocin (e.g., severe liver disease, seizure disorder, metabolic disorder); past history of allergic reaction to oxytocin and its nasal spray product.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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

The Oxytocin group and the comparison group ran side by side rather than switching.

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

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

It started in 2017-01-27 with completion listed for 2021-08-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Affective Reactivity Index - Youth (ARI-Y) (time frame: baseline and 21 days). Clinical Global Impression: Severity (time frame: 21 days (study endpoint)).

It also tracked 1 secondary outcome, for example Functional MRI (fMRI) BOLD Response Changes.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 58 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.