Oxytocin as Adjunctive Therapy for Schizophrenia

What Was Tested

This registered phase 2 trial tested Oxytocin.

Aims: The project has two main aims, listed below: 1.

It had two arms (groups): Oxytocin (experimental) and Placebo vial (placebo comparator).

Each treatment will consist of 10 insufflations (5/nostril alternating between nostrils) of placebo Spray, which contains all OXT Spray ingredients except for oxytocin.

The registry classes the interventions as drug.

More on the Plan

The project has two main aims: 1.

Aims of the neuropsychological assessment To use an Emotional Priming Paradigm (EPP) task to assess pre- and post-treatment change in the patients general cognitive and emotional status.

The investigators aim at treating a large sample size of patients with schizophrenia, consisting exclusively of patients with a limited disorder duration and rather young age, for a sufficiently long period of time.

Moreover, only patients with a disorder onset of 10 years or less will be enrolled.

Who Took Part

32 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Patients with a diagnosis of SZ, according to DSM-IV criteria, for at least one year, evaluated with SCID/P. A minimum PANSS total score of 55 (indicating moderate severity, due to ongoing AP treatment) . A minimum CGI-S score of 4. Age between 18 and 45 years. A disorder duration of no longer than 10 years.

The full record lists 11 inclusion and 9 exclusion criteria; among the exclusions: diagnosis of mental retardation; diagnosis of organic mental disorder; history of no response to treatment with clozapine.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

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

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

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 2014-01 with completion listed for 2015-04.

It ran at 7 sites in Italy (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in PANSS negative score, as measured at T0 and at 2,4,6 and 8 months (time frame: 8 months).

It also tracked 1 secondary outcome, for example PANSS total score change.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 32 people.

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

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.