Adult Oxytocin Study

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 quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia.

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

120 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 to 65 years of age. Meet Diagnostic and Statistical Manual (DSM)-IV criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder. No or at most only minor changes to medications in the past week. Able to use nasal spray. Must be capable of providing informed consent.

The full record lists 12 inclusion and 6 exclusion criteria; among the exclusions: active substance abuse or dependence as determined by a urine toxicology drug screening; A current DSM-IV diagnosis of any disorder other than schizophrenia; hearing deficits.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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.

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 2010-08 with completion listed for 2015-11.

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

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example Pre-morbid IQ Questionnaire (AmNART), Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire, Childhood Trauma Questionnaire (CTQ), Emotional Quotient Scale (EQS), Kinsey Scale and Change in Working Memory capacity.

What This Means in Plain Language

Put simply, this is a early phase 1, 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.