Target Engagement for Oxytocin: Dose Ranging Study

What Was Tested

The trial (not phased) is built around Oxytocin.

The targets are (1) the suppression of a particular wave form (mu) on the electroencephalogram (EEG) while subjects observe a socially relevant form of motion and (2) pupil dilation will subjects identify faces showing different emotions.

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

Subjects will be administered intranasal placebo using the same spray volume as experimental condition.

The registry classes the interventions as drug.

More on the Plan

Thirty minutes following the drug administration patients will be evaluated on the EEG and pupillometry tasks followed by two tests that evaluate social salience.

One week later subjects will have a second challenge in the alternative (drug or placebo) condition.

Who Took Part

The registry lists 51 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Schizophrenia, Schizoaffective Disorder, Delusional Disorder. Able to cooperate with study procedures.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: serious medical condition or substance use.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

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.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

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 and outcomes assessor.

It started in 2015-09 with completion listed for 2017-07-01.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Mu Suppression on EEG (time frame: Baseline, 1 Week). Pupil Dilation While Observing Faces (time frame: Baseline, 1 Week).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 51 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.