Oxytocin Administration in BDD and OCD

What Was Tested

The trial (phase 2) is built around Oxytocin.

The purpose of the current study is to investigate the effect of an acute administration of intranasal oxytocin, relative to placebo, on social cognitive impairments among individuals with body dysmorphic disorder and obsessive-compulsive disorder, compared to healthy controls.

It had two arms (groups): Oxytocin, Then Placebo (experimental) and Placebo, Then Oxytocin (experimental).

The registry classes the interventions as drug.

More on the Plan

A closer examination of biological mechanisms underlying psychopathology may help uncover mechanisms to target during intervention and thereby provide a novel approach to treatment.

Given that the neuropeptide, oxytocin, is involved in the regulation of a variety of social and cognitive dimensions, including emotion recognition and social attentional processing, there are direct implications regarding its role in the development of such deficits among individuals with BDD.

The current study therefore aims to investigate the effect of oxytocin administration on social cognitive impairments in BDD and a related disorder, OCD.

Twenty treatment-seeking male and female outpatients with BDD, 20 individuals with OCD, and 20 healthy participants will be assigned to receive an oxytocin and placebo nasal spray one week apart.

Who Took Part

Enrollment: 41 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Treatment-seeking adult males and females ≥ 18 years of age. Meets DSM-IV criteria for principal BDD (for BDD group) or principal OCD (for OCD group), as determined by Structured Clinical Interview for DSM-IV (SCID) diagnostic interview. For healthy volunteers only: does not meet current DSM-IV diagnosis of any Axis I disorder.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: smokers who smoke ≥ 15 cigarettes daily; serious medical illnesses; active homicidal or suicidal ideation.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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.

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant and investigator.

It started in 2014-12 with completion listed for 2017-10.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Emotion Recognition Questionnaire (time frame: 45 minutes post nasal spray administration).

It also tracked 3 secondary outcomes, for example Interpretation Questionnaire, Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task and Amount of Initial Monetary Transfer During Trust Game.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 41 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.