Oxytocin Treatment of Schizophrenia

What Was Tested

The trial (not phased) is built around Oxytocin.

Participants: Up to 80 adults with schizophrenia for at least one year and with a high rating for paranoia.

It had two arms (groups): intranasal spray with oxytocin (experimental) and intranasal spray without oxytocin (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

Individuals judged unable to learn self-administration of intranasal treatments and/or not sufficiently reliable to do so will be excluded.

Abnormalities found during medical evaluation will be grounds for exclusion (see details below) although subjects with laboratory measures somewhat out of the normal range may be included at the discretion of Drs.

Pedersen, Gilmore, Rau and/or Salimi.

Study Design: Randomized, double-blind, placebo-controlled design.

Who Took Part

17 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Meeting DSM-IV criteria for paranoid or undifferentiated schizophrenia for at least 1 year.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: low literacy as indicated by an inability to read and understand the consent form; dependence on substances other than tobacco or caffeine; positive urine drug screen for illegal substances or drugs that have not been prescribed.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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

The Oxytocin group and the comparison group ran side by side rather than switching.

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 outcomes assessor.

It started in 2009-11 with completion listed for 2011-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point (time frame: 6 weeks). Theory of Mind as Measured by the Eyes Test at 6 Weeks (time frame: 6 weeks). Theory of Mind as Measured by the Brune Test at 6 Weeks (time frame: 6 weeks).

It also tracked 1 secondary outcome, for example Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 17 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.