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Intranasal Oxytocin in Antiosocial Personality Disorder and Psychopathy

Plain-language guide to NCT05383300: not phased randomized trial of Oxytocin, 72 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05383300
Phase
not phased
Status
completed
Start
2017-05-01
Completion (planned or actual)
2020-03-01
Participants
72 (actual)
Design
randomized, triple-blind, other
Conditions studied
Antisocial Personality Disorder
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Oxytocin.

It had three arms (groups): Violent offenders with psychopathy (other), Violent offenders without psychopathy (other) and Healthy non-offenders (other).

Violent offenders with psychopathy.

Violent offenders without psychopathy.

Healthy non-offenders.

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 72 actual participants took part.

It was open to men only aged from 18 years up to 60 years.

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

Examples of who could join: IQ greater than 70 as defined by the Wechsler Abbreviated Scale of Intelligence (WASI-II).

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: history of major mental disorders (bipolar 1, bipolar 2, major depression or psychotic disorders); self-reported neurological disorders; head injury resulting in loss of consciousness for 1 hour or longer.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

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

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

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, care provider and investigator.

It started in 2017-05-01 with completion listed for 2020-03-01.

It ran at 1 site in United Kingdom.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Within-group effect of oxytocin on nerual modulation of fear (time frame: 10 minutes).

It also tracked 1 secondary outcome, for example Baseline neural modulation of morphed fearful faces.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 72 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.

Our Notes on the Compound

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.