The Association of Affective Resonance With Empathy Modulated by Negative Symptomatology and Oxytocin

What Was Tested

The trial (not phased) is built around Oxytocin.

The purpose of this study is to investigate the effect of oxytocin on empathy in patients with schizophrenia.

On a neurobiological level, social effects mediated by oxytocin are based on oxytocin's influence on the complexly regulated mesocorticolimbic dopamine system.

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

The registry classes the interventions as other.

More on the Plan

The study design is based on an experimental, double-blinded (participants, instructor), placebo-controlled, proof-of-concept randomized, trial and complies with the CONSORT guidelines.

All study-relevant measures were based on the current Declaration of Helsinki.

After eligibility screening, informed consent was obtained at least 24 hours before participants started baseline assessments.

Participants were randomly allocated to the experimental condition with admission of oxytocin or to a placebo treatment as the active control condition with MBGT as a positive social context in each condition.

Who Took Part

41 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Psychiatric diagnosis from the schizophrenic spectrum (ICD-10: F2x.x spectrum) for group of patients. Mild to moderate positive symptoms (5 \< positive symptoms on individual items using P-PANSS). Age: 18 - 65 years. German should either be the mother tongue or spoken at a native level.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: acute psychotic episode with severe positive symptoms (icd-10: f2 spectrum, 5 ≥ positive symptoms on individual items using p-panss); acute suicidality; acute consumption phase of a substance dependence, except nicotine.

How the Study Was Run

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

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

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 care provider.

It started in 2021-08-02 with completion listed for 2021-11-25.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in empathy (time frame: Change from baseline (before intervention) to directly after intervention).

It also tracked 1 secondary outcome, for example Change of negative symptoms.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 41 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.