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Completed

NCT Number: NCT05383300

Intranasal Oxytocin in Antiosocial Personality Disorder and Psychopathy

A pharmacoimaging study of oxytcoin in antisocial personality disorder and psychopathy

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Key information

Conditions

Antisocial Personality Disorder Mental Disorders Personality Disorders

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Insititue of Psychiarty, Psychology and Neuroscience

London, Nottinghamshire, SE58AF, United Kingdom

About this study

Using a double-blinded, placebo controlled design, we explored similarities and differences in i) an important component of empathic processing (neural response to facial emotional expressions) and ii) decision-making in violent men with ASPD+/-Psychopathy, compared to healthy non-offenders (NO; n= 21 across studies), with placebo and after acute application of intranasal oxytocin, using functional Magnetic Resonance Imaging (fMRI).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • Aged 18-60
  • IQ greater than 70 as defined by the Wechsler Abbreviated Scale of Intelligence (WASI-II).

Violent offenders:

Offenders with convictions for violent crimes (murder, rape, attempted murder, grievous and actual bodily harm) who met DSM-5 criteria for antisocial personality disorder (Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5 PD) Psychopathy or non-psychopathy subgroup based on Psychopathy Checklist- Revised (PCL-R; (Hare, 2003))- score of 25 as the threshold for psychopathy in this English population.

Healthy non-offenders:

Non-offenders with no personality disorder

Exclusion criteria

  • 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
  • severe visual or hearing impairments
  • contraindications to MRI

Treatment and study plan

Oxytocin nasal spray

Drug

Intranasal spray containing 40 IU of oxytocin

Placebo spray

Other

Application of inert placebo, identical in odor, color, and droplet size except for absence of oxytocin

Primary outcomes

  1. Within-group effect of oxytocin on nerual modulation of fear

    Time frame: 10 minutes

    Differences in responsivity to morphed faces on FMRI in oxytocin vs fear condition- clusterwise analysis using AFNI (effect size is beta values)

Secondary outcomes

  1. Baseline neural modulation of morphed fearful faces

    Time frame: 10 minutes

    Response to morphred faces on FMRI in placebo condition- clusterwise analysis using AFNI (effect size is beta values)

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Father Flanagan's Boys' Home

Registry information

Official study title

Investigating the Effect of Oxytocin and the Neurochemistry of Antisocial Personality Disorder and Psychopathy Using Neuroimaging

Acronym: OXYASP

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
May 20, 2022
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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