The Effects of Intranasal and Oral Administration of Oxytocin on Responses to Emotional Scenes

What Was Tested

The trial (not phased) is built around Oxytocin.

It had four arms (groups): Oral Oxytocin (active comparator), Intranasal Oxytocin (active comparator), Oral placebo (placebo comparator) and Intranasal placebo (placebo comparator).

Administer placebo orally (identical ingredients, except the active agent).

The registry classes the interventions as drug.

More on the Plan

Previous studies have reported that oxytocin administration intranasally and orally (spray on the tongue) can modulate neural and behavioral responses during processing of face emotions and can influence top-down attention to social stimuli.

However, no research has directly compared the neural and behavioral effects of the two different administration routes on the processing of emotional scenes.

Additionally, the Positive and Negative Affect Schedule (PANAS) is administered before the treatment and before and after completing the implicit emotional scanning task to measure any changes in mood.

Forty-five minutes after receiving treatment, subjects will be required to undergo and MRI scanning session including structural scans and resting-state fMRI followed by an implicit emotional scene processing task (picture source: Nencki affective picture system, including positive, neutral, and negative-valence social and non-social scenes).

Who Took Part

Enrollment: 160 planned participants were the target.

It was open to men only aged from 18 years up to 30 years.

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

Examples of who could join: Healthy subjects without any past or present psychiatric or neurological disorders.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: 1\. history of brain injury 2. head trauma 3. substance abuse 4. medication.

How the Study Was Run

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

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

The Oxytocin group and the comparison group ran side by side rather than switching.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2022-09-20 with completion listed for 2022-12-20.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Compare the effects of oxytocin on neural responses to emotional scenes between intranasal and oral administration routes (time frame: 45~70 minutes after treatment). Compare the effects of oxytocin on behavioral responses to emotional scenes between intranasal and oral administration routes (time frame: 70~90 minutes after treatment).

It also tracked 5 secondary outcomes, for example Correlations between neural activation and behavioral effects of intranasal or oral oxytocin during emotional scene processing, Correlations between functional connectivity and behavioral effects of intranasal or oral oxytocin during emotional scene processing and Mood changes assessed by the Positive Affect Negative Affect Schedule (PANAS) in all treatment groups during the experiment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 160 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.