Effects of Intranasal Oxytocin on Emotion Regulation in Adolescents

What Was Tested

This registered phase 1 trial tested Oxytocin.

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

The registry classes the interventions as drug.

More on the Plan

Emotional dysregulation and impaired attachment in adolescence are seen by clinical researchers as potential contributors to development of psychopathology.

However, to date there have been no studies investigating the effects of intranasal OT on parent-adolescent interaction and on neurophysiological emotional strategies in adolescence.

To understand these mechanisms, this study examines the effects of OT on interpersonal emotional regulation in adolescent-parent stressful interaction, and on individual visual and physiological strategies in the visualizing attachment-related emotions pictures.

Adolescent will be invited with his/her parent to an experimental conflict discussion.

Who Took Part

The registry lists 29 actual participants took part.

It was open to men only aged from 13 years up to 20 years.

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

Examples of who could join: Male adolescents (and parents) enrolled in high school or college. Without current or past history of neurological or psychiatric illness, including substance abuse or dependence. Aged from 13 to 20 years. Have signed informed consent. Affiliation to a French social security.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: intellectual deficit; severe neurological symptoms; known allergies to oxytocin or to preservatives in the nasal spray.

How the Study Was Run

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

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

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

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, care provider, investigator and outcomes assessor.

It started in 2014-04-29 with completion listed for 2017-05-31.

It ran at 1 site in France.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Conflict discussion (time frame: 3 years).

It also tracked 1 secondary outcome, for example Visual patterns.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 29 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.