Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations

What Was Tested

In this phase 1 trial, researchers set out to test Oxytocin.

Social cognition impairment is critical to the pathology and morbidity of a number of psychiatric disorders, including the schizophrenia spectrum, the autism spectrum and the personality disorders, thus representing a dimension consistent with RDoC.

It had five arms (groups): Intranasal Oxytocin Group 1 (active comparator), Intranasal Oxytocin Group 2 (active comparator), Intranasal Oxytocin Group 3 (active comparator), Intranasal Oxytocin Group 4 (active comparator) and Intranasal Oxytocin Group 5 (active comparator).

The registry classes the interventions as drug.

More on the Plan

However, the specificity and mechanisms of these impairments remain unclear.

The researchers propose here to examine the effects of oxytocin, known to be a key regulator of social cognition through modulating frontolimbic neural circuitry, on social cognition in schizotypal and borderline patients.

Social cognitive testing will be performed 45 minutes after drug/placebo administration in an identical protocol each time.

The social cognitive test serving as primary outcome measure will be the Movie for the Assessment of Social Cognition (MASC).

Who Took Part

92 actual participants took part.

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

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

Examples of who could join: 18 ≤ age ≤ 65. Willing and able to provide informed consent.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: currently meets for a psychotic episode; currently meets dsm-iv-tr criteria for mdd; current substance abuse (last 6 months) or past dependence on stimulants, opioids or other potentially neurotoxic drugs.

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.

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, investigator and outcomes assessor.

It started in 2013-09 with completion listed for 2020-07.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Movie for the Assessment of Social Cognition (MASC) (time frame: Day 1). Movie for the Assessment of Social Cognition (MASC) (time frame: Day 29). Movie for the Assessment of Social Cognition (MASC) (time frame: Day 57).

It also tracked 5 secondary outcomes, for example Reading of the Mind in the Eyes, Reading of the Mind in the Eyes, Reading of the Mind in the Eyes, Resting-state functional connectivity and Resting-state functional connectivity.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 92 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.