Intranasal Oxytocin in Antiosocial Personality Disorder and Psychopathy

Not Applicable

Completed

• Conditions: Antisocial Personality Disorder
• Interventions: Drug: Oxytocin nasal spray; Other: Placebo spray

• Registration Number: NCT05383300
• Lead Sponsor: King's College London

Brief Summary

A pharmacoimaging study of oxytcoin in antisocial personality disorder and psychopathy

Detailed Description

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).

Study Timeline

• Study Start: 2017-05-01
• Primary Completion: 2020-03-01
• Status Verified: 2021-12
• Study Completion: 2021-12-01
• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-05-16
• Last Update Submitted: 2022-05-16
• Study First Posted: 2022-05-20
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Violent offenders with psychopathy	Oxytocin nasal spray	Violent offenders with psychopathy
Violent offenders with psychopathy	Placebo spray	Violent offenders with psychopathy
Violent offenders without psychopathy	Oxytocin nasal spray	Violent offenders without psychopathy
Violent offenders without psychopathy	Placebo spray	Violent offenders without psychopathy
Healthy non-offenders	Placebo spray	Healthy non-offenders
Healthy non-offenders	Oxytocin nasal spray	Healthy non-offenders

Primary Outcome Measures

Name	Time	Method
Within-group effect of oxytocin on nerual modulation of fear	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 Outcome Measures

Name	Time	Method
Baseline neural modulation of morphed fearful faces	10 minutes	Response to morphred faces on FMRI in placebo condition- clusterwise analysis using AFNI (effect size is beta values)

Trial Locations

Locations (1)

Insititue of Psychiarty, Psychology and Neuroscience; 🇬🇧 London, Nottinghamshire, United Kingdom