Open-label Study of the Efficacy of Intranasal Oxytocin in Schizophrenia

What Was Tested

The trial (not phased) is built around Oxytocin.

It had two arms (groups): one (experimental) and Vehicle placebo (sham comparator).

Oxytocin twice daily for 3 weeks.

Placebo for 3 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 14 actual participants took part.

It was open to people of any sex aged from 18 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, 18 years of age or older. Meet DSM-IV criteria for Schizophrenia. A minimum PANSS total score of 55 at 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 5 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

The set-up was randomized, single-group and open-label.

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

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-03 with completion listed for 2014-12.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

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 28 Weeks (time frame: baseline and 28 weeks).

It also tracked 5 secondary outcomes, for example Global Assessment of Functioning (GAF), Clinical Global Impression-Severity, Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®) and Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 14 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.