The Effect of Intranasal Administration of Oxytocin on Empathic Abilities.

What Was Tested

This registered phase 2 trial tested Oxytocin.

Two sets of theoretical mechanisms were designed in order to explain how empathy is possible.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

Oxytocin.

Placebo.

The registry classes the interventions as drug.

More on the Plan

Social cognition encompasses a wide spectrum of abilities, enabling them to function properly in interpersonal interactions.

Schizophrenia encompasses a wide spectrum of psychotic disorders, characterized by severe cognitive, emotional and behavioral impairments.

In a recent study, Domes et al.

Simulation will be tested in two different tasks: emotion recognition via a dynamic paradigm of facial expressions, and recognition of biological motion, which necessitates the identification of the emotion conveyed in a video clips of point light walkers.

Who Took Part

The registry lists 100 planned participants were the target.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Range of age between 18 and 45 years. The patient is diagnosed as suffering from schizophrenia by 2 independent psychiatrists, according to DSM-IV criteria. The participant is able to commit to 2 trials with 7 days interval. The participant has been informed orally and in writing and has given his/her written consent. When necessary, a psychiatrist has determined the patient's ability to agree, orally and in writing.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: the participant is suffers from an axis ii disorder of dsm-iv; the participant has history of alcohol or drug abuse; the participant is pregnant or breast-feeding.

How the Study Was Run

Design: randomized, crossover and double-blind.

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

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

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 2008-05 with completion listed for 2010-01.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: accuracy level (in percentage) and reaction time (in milliseconds) of emotional facial expressions recognition in a dynamic emotional facial expressions task (time frame: end of second trial for each subject).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.