Effects of Oxytocin on Negative Symptoms and Social Cognition in Schizophrenia and Its Possible Mechanisms

What Was Tested

This registered not phased trial tested Oxytocin.

The purpose of this study was to investigate the effects of oxytocin on negative symptoms and social cognitive task performance in schizophrenia.

The investigators conducted a randomized, placebo-controlled trial testing the effects of twice daily intranasal oxytocin treatment for 14 days on psychotic symptoms and social cognition in patients with schizophrenia.

It had two arms (groups): schizophrenia with oxytocin (experimental) and schizophrenia with Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Social impairment is a primary cause of disability in schizophrenia, responds poorly to current antipsychotic medications and is related to deficits in social cognitive abilities, which include Theory of Mind, emotion recognition and attributional style.

In this study, the investigators conducted a randomized, placebo-controlled trial testing the effects of twice daily intranasal oxytocin treatment for 14 days on psychotic symptoms and social cognition in patients with schizophrenia.

The investigators will recruit patients with schizophrenia, screening of subjects included a review of psychiatric and medical history, physical examination, baseline social cognition measures were obtained followed by psychiatric ratings.

Daily intranasal treatments were initiated after baseline assessments.

Who Took Part

The registry lists 43 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

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

Examples of who could join: Aged between 18 and 55 years;. DSM-IV diagnosis of schizophrenia, acute schizophreniform disorder, or schizoaffective disorder.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: presence of other psychiatric diagnoses (e.g., depression);; active misuse of substance or alcohol;; intellectual disability (iq \< 70);.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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 and investigator.

It started in 2018-07-21 with completion listed for 2020-03-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The Positive and Negative Syndrome Scale (PANSS) (time frame: baseline). The Positive and Negative Syndrome Scale (PANSS) (time frame: the two-week endpoint). The Clinical Assessment Interview for Negative Symptoms (CAINS) (time frame: baseline).

It also tracked 10 secondary outcomes, for example Reinforcement Learning Task, Reinforcement Learning Task, The Temporal Experience of Pleasure Scale (TEPS), The Temporal Experience of Pleasure Scale (TEPS), Interpersonal Reactivity Index (IRI) and Interpersonal Reactivity Index (IRI).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 43 people.

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.