Effects of Oxytocin Nasal Spray on Social Affiliation

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom domains and functional impairments.

One of the strategies of novel drug development depends on identifying heritable physiological deficits that mark the disease liability and are thought to occur along the causal pathway of negative symptoms.

It had two arms (groups): Oxytocin, then Placebo (experimental) and Placebo, then Oxytocin (experimental).

Participants first received a placebo (saline nasal spray) administered intranasally with 6 total sprays (three in each nostril) on the morning and at midday of one study visit. Then, after at least month the participants returned for a second study day and received Oxytocin.

The registry classes the interventions as drug.

More on the Plan

The current study will examine the effects of intranasal oxytocin on physiological/cognitive markers of negative symptoms in 24 participants with schizophrenia spectrum traits.

Subjects will be tested in two one-day studies carried out at least a month apart.

Who Took Part

27 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Male/Female subjects between ages of 18-64 years. The presence of 3 or more SSP symptoms (at least 2 of the SSP symptoms will be negative symptoms as defined by the schizoid traits). Relative of an individual with schizophrenia, schizo-affective, or schizophreniform disorder. Able to provide written informed consent. Females are excluded due to risk of discomfort and unblinding due to potential uterine cramps induced by oxytocin.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: received any investigational drug in the preceding four weeks.

How the Study Was Run

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

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

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

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, investigator and outcomes assessor.

It started in 2009-10 with completion listed for 2015-07.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Social Affiliation Measured by Social Affiliative Role Play (time frame: 30 minutes).

It also tracked 8 secondary outcomes, for example Hopkins Verbal Learning Test (HVLT), Trust Game, RVIP Reaction Times, Rapid Visual Information Processing Test (RVIP), Brief Assessments of Cognition for Schizophrenia and Brief Smell Identification Test.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 27 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.