Oxytocin MEG Study

What Was Tested

The trial (early phase 1) is built around Oxytocin.

The specific aim of this proposal is to investigate the neurophysiological mechanisms of oxytocin's (OT) prosocial effects in patients with schizophrenia and healthy subjects using magnetoencephalography.

Hypothesis A: When OT is administered to patients with schizophrenia, fear-related amygdala hyperreactivity and fusiform gyrus (FG) and anterior cingulate cortex (ACC) hypoactivity will be normalized.

It had two arms (groups): Interventional (active comparator) and Saline Nasal Spray (placebo comparator).

Placebo Comparator.

The registry classes the interventions as drug.

Who Took Part

The registry lists 40 actual participants took part.

It was open to men only aged from 18 years up to 40 years.

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

Examples of who could join: 18-40 years of age. Must comprehend English. Meet DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorder. None or only minor changes to medications in the past week. Able to use nasal spray.

The full record lists 15 inclusion and 7 exclusion criteria; among the exclusions: active substance abuse or dependence as determined by a urine toxicology drug screening; DSM-IV diagnosis of any disorder other than schizophrenia; hearing deficits.

How the Study Was Run

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

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant and investigator.

It started in 2012-02 with completion listed for 2016-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in MEG neural activation patterns (time frame: Oxytocin and placebo administration days at least 1-week apart).

It also tracked 10 secondary outcomes, for example Change in performance on Facial Recognition Task, Change in performance on International Affective Picture System (IAPS) task, UCLA Loneliness Scale, Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire, Childhood Trauma Questionnaire (CTQ) and Parental Bonding Instrument (PBI).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 40 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.