Target Engagement and Response to Oxytocin

What Was Tested

In this phase 4 trial, researchers set out to test Oxytocin.

This study will measure whether the engagement of intranasal oxytocin with a brain target is related to effects on learning during a social cognition training program.

It had four arms (groups): Oxytocin with SCST (experimental), one (sham comparator), Placebo with SCST (placebo comparator) and Placebo with HM (placebo comparator).

Oxytocin with SCST (active condition).

Administration of OT with control psychosocial treatment.

Administration of Placebo with active psychosocial treatment.

The registry classes the interventions as behavioral and drug.

More on the Plan

The study will determine whether oxytocin (OT) administration 30 min before a training session enhances the learning of social information in the context of a social cognitive skills training (SCST) program, and it will test a possible mediator of this effect.

Subjects with psychotic disorders will be randomized to one of four groups in a 2 by 2 factorial design: OT with SCST; Placebo with SCST; OT with training control condition; placebo with training control condition.

Target engagement will be measured in an OT challenge (placebo versus OT one week apart) prior to baseline assessment.

The measure of target engagement will be EEG mu suppression while observing biological motion.

Who Took Part

The registry lists 120 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 or schizoaffective disorder. Stable on an antipsychotic medication.

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: positive pregnancy test history of head injury.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

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

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 2018-01-04 with completion listed for 2024-07-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Social Cognition Composite Score (time frame: 16 weeks).

It also tracked 1 secondary outcome, for example Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 120 people.

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.