Adult Study Oxytocin - fMRI

What Was Tested

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

In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia.

Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia.

Aim 1: To examine the effects of exogenous oxytocin on patterns of neural activation as measured by fMRI during a well-characterized affect-labeling task in patients with recent-onset schizophrenia and healthy comparison subjects.

It had two arms (groups): Oxytocin (experimental) and Saline Nasal Spray (placebo comparator).

Placebo Comparator.

The registry classes the interventions as drug.

Who Took Part

59 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

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

Examples of who could join: SCID-IV confirmed diagnosis of schizophrenia or schizoaffective disorder. No changes to medications for the past week. SCID-IV confirmed no diagnosis of a current Axis I disorder within the last year.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: any illness that affects the nasal passages and impairs the delivery of a nasal spray; A pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos; hearing difficulties.

How the Study Was Run

Design: randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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 2012-09 with completion listed for 2017-09.

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

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in fMRI neural activation patterns (time frame: 2-days at least 1-week apart).

It also tracked 10 secondary outcomes, for example Quality of Life Scale (QLS), Social Functioning Scale (SFS), UCLA Loneliness Scale, Experiences in Close Relationships - Relationship Structures (ECR-RS), Parental Bonding Instrument (PBI) and Premorbid IQ test (AmNART).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 59 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.