The Moderating Role of Baseline Oxytocin on Its Psychotherapy-facilitating Effects Among Patients With Eating Disorders

What Was Tested

The trial (phase 1) is built around Oxytocin.

One group of patients affected by social are patients with eating disorders (EDs).

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

The registry classes the interventions as drug.

More on the Plan

Based on correlations found between OT levels and psychiatric symptoms, such as social manifestations, trust and social cognition.

One group of patients known to be profoundly affected by deficits in social bonding, social cognition and trust are patients with eating disorders (EDs).

In this study investigators aim to examine the effects of OT administration among patients with eating disorders (EDs), while focusing on baseline OT levels and interpersonal abilities as potential moderators and/or mediators of its effects.

(2) What are the moderators and mediators of these effects, and specifically, do baseline levels of OT and baseline interpersonal abilities moderate these effects?

Who Took Part

90 planned participants were the target.

It was open to people of any sex aged from 16 years up to 60 years.

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

Examples of who could join: Verified diagnosis of ED. At least four weeks of treatment at the EDs unit.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: no ongoing medical care; immediate suicidal or violent risk; inability to complete self-report measures for any reason.

How the Study Was Run

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

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.

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 2023-06-30 with completion listed for 2024-04-30.

It ran at 2 sites in Israel (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): eating disorder symptoms (time frame: 6 weeks).

It also tracked 4 secondary outcomes, for example general symptomatic distress, cognitive rigidity, social deficits and working alliance.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 90 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.