Does Acute Oxytocin Administration Enhance Social Cognition in Individuals With Schizophrenia?

What Was Tested

This registered not phased trial tested Oxytocin.

Individuals with schizophrenia have been found to have deficits in social cognition, which is defined as the functions that are engaged during social interactions.

Social cognition has been found to be critical in predicting multiple aspects of community functioning.

It had two arms (groups): Inactive nasal spray (placebo comparator) and Intranasal Oxytocin (experimental).

A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.

The registry classes the interventions as drug.

More on the Plan

Schizophrenia is characterized by the presence of positive symptoms (delusions, hallucinations, disorganization of thought process and behavior) as well as negative symptoms (blunted affect, alogia, and avolition), neurocognitive deficits, and impaired social cognition.

While positive symptoms can often respond well to antipsychotic medications, the latter symptoms are more difficult to treat.

In this study, the researchers will focus on social cognition, which is defined as the functions that are engaged during social interactions.

Social cognition has been categorized into four main domains: theory of mind, social perception, attributional bias, and emotional processing.

Who Took Part

24 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: Meet DSM-IV-TR criteria for Schizophrenia. At least 1 month since meeting the criteria for having a major depressive episode. Adherence to the regular administration of an antipsychotic medication (e.g., risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, paliperidone, iloperidone, asenapine, fluphenazine, haloperidol, loxapine, molindone, perphenazine, thiothixene, chlorpromazine, clozapine). No acute medical problems. Chronic medical conditions (e.g., hypertension, diabetes, dyslipidemia) consistently treated and stable for at least 3 months prior to study participation.

The full record lists 10 inclusion and 6 exclusion criteria; among the exclusions: documented history of mental retardation or severe learning disability; history of treatment with electroconvulsive therapy within 6 months prior to study participation; history of neurological or neuropsychiatric condition (e.g., stroke, severe traumatic brain injury, epilepsy, etc.).

How the Study Was Run

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

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2011-04 with completion listed for 2012-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Social Cognition Composite Measure (time frame: Visit 2 (baseline), Visit 3 (1 week following, post-treatment)).

It also tracked 5 secondary outcomes, for example Theory of Mind Assessment (High Level Social Cognition), Empathy, Social Perception Assessment (Low Level Social Cognition), Facial Affect Recognition (Low Level Social Cognition) and Positive and Negative Syndrome Scale (PANSS) for Schizophrenia Total Score.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 24 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.