Antipsychotic Effects of Oxytocin

What Was Tested

This registered not phased trial tested Oxytocin.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

This is two-site clinical study taking place at UCSD and UCI.

Approximately 71 patients at each site will be randomly assigned to either intranasal oxytocin or vehicle placebo at this site.

The total duration for each individual subject will be 6 weeks on study medication (placebo or oxytocin).

Who Took Part

Enrollment: 42 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: Adult men or women, 21 years of age or older. Meet DSM-IV criteria for Schizophrenia. A minimum PANSS total score of 55 at screening and baseline and a score of at least 4 (moderate) on the subscale of the PANSS (suspiciousness/persecution) at screening. Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline. Must be able to use nasal spray.

The full record lists 9 inclusion and 6 exclusion criteria; among the exclusions: are pregnant or are breastfeeding (negative pregnancy test at screening); A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse; any active medical condition that in the opinion of the investigator will interfere with the objectives of the study.

How the Study Was Run

It was run as a randomized, parallel-group and triple-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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2011-06 with completion listed for 2018-12.

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 Total Score in the Positive and Negative Syndrome Scale (PANSS)From Baseline to Endpoint (time frame: 6 weeks).

It also tracked 14 secondary outcomes, for example Global Assessment of Functioning (GAF), Clinical Global Impression-Severity of Illness (CGI-S), Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®), Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME), Calgary Depression Scale for Schizophrenia (CDSS) and Hamilton-Anxiety Scale (HAM-A).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 42 people.

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.