The Impact of Oxytocin on the Neurobiology of Anorexia Nervosa

What Was Tested

This registered early phase 1 trial tested Oxytocin.

This study will use a randomized, controlled, double-blind design involving the administration of intranasal oxytocin (INOT) or placebo to adults with anorexia nervosa, restricting subtype and age-matched controls prior to neuroimaging to assess the impact on frontolimbic brain activity in response to socioemotional stimuli as well as eating behavior in a test meal paradigm.

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

Intranasal placebo.

Intranasal oxytocin.

The registry classes the interventions as biological.

More on the Plan

The primary objective of this investigation is to determine the impact of oxytocin (OT), a peptide hormone that influences social affiliation, on socioemotional neural circuitry and eating disorder behavior in anorexia nervosa (AN).

Because socioemotional processing deficits appear to play a key role in AN, OT is implicated as a potential biological mechanism by which eating disorder behavior (e.g., restrictive eating) is maintained.

Used as a probe, intranasal oxytocin (INOT) provides an innovative method for examining the short-term impact of OT on socioemotional neural processing disturbances and eating disorder behavior in AN.

The proposed study tests a theoretical model of the role of OT in the maintenance of AN by using an INOT probe to determine, and potentially alter, neurobiological responses to socioemotional stimuli.

Who Took Part

The registry lists 16 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Age \> 18 years old. Female (given the potential sex differences to endogenous OT to INOT). Ability to read and speak in English. Anorexia nervosa participants:. DSM-5 diagnosis of AN, restricting subtype (established by the SCID-5-RV),.

The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: medical instability or current pregnancy or lactation; current substance use disorder, psychosis, or bipolar-i disorder; contraindication for fmri (e.g., implanted metal).

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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, investigator and outcomes assessor.

It started in 2018-09-25 with completion listed for 2021-04-30.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Test meal (time frame: Following intranasal oxytocin or placebo (within 1-3 hours)). fMRI measures (time frame: Following intranasal oxytocin or placebo administration (within 1-3 hours)).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 16 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.