A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia

What Was Tested

This registered phase 2 trial tested Oxytocin.

Schizophrenia has a devastating and disproportionate effect on veterans compared to the general US population.

This means that veterans with schizophrenia have trouble navigating interpersonal interactions and building meaningful relationships in the community.

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

Saline.

The registry classes the interventions as drug.

More on the Plan

The study uses a combined within- and between-subject placebo-controlled study design.

Within subjects phase: After screening, participants will be randomized into two study arms for the fMRI phase of the study.

Before and after the three weeks of drug administration, participants will be assessed for social functioning, social ability, negative symptoms, and theory of mind.

Who Took Part

The registry lists 26 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: A diagnosis of schizophrenia, schizophreniform, schizoaffective, or brief psychotic disorder determined by the Structured Clinical Interview for DSM-5. No medication changes or psychiatric hospitalizations in the past month. SFS modified raw score of no more than 75.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: substance use disorder in the past month, except mild to moderate cannabis use disorder; illness affecting the nasal passages; extensive dental work.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

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 2020-01-13 with completion listed for 2024-01-31.

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

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Social Functioning Score.

It also tracked 1 secondary outcome, for example CAINS Score (Clinical Assessment Interview for Negative Symptoms).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 26 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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