Intranasal Oxytocin in Antiosocial Personality Disorder and Psychopathy (OXYASP)

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

A pharmacoimaging study of oxytcoin in antisocial personality disorder and psychopathy

Study Overview

• Status: Completed
• Conditions: Antisocial Personality Disorder
• Intervention / Treatment: Drug: Oxytocin nasal spray; Other: Placebo spray

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • London, Nottinghamshire, United Kingdom, SE58AF
      • Insititue of Psychiarty, Psychology and Neuroscience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Violent offenders with psychopathy	Drug: Oxytocin nasal spray; Intranasal spray containing 40 IU of oxytocin; Other: Placebo spray; Application of inert placebo, identical in odor, color, and droplet size except for absence of oxytocin
Other: Violent offenders without psychopathy	Drug: Oxytocin nasal spray; Intranasal spray containing 40 IU of oxytocin; Other: Placebo spray; Application of inert placebo, identical in odor, color, and droplet size except for absence of oxytocin
Other: Healthy non-offenders	Drug: Oxytocin nasal spray; Intranasal spray containing 40 IU of oxytocin; Other: Placebo spray; Application of inert placebo, identical in odor, color, and droplet size except for absence of oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Within-group effect of oxytocin on nerual modulation of fear	Differences in responsivity to morphed faces on FMRI in oxytocin vs fear condition- clusterwise analysis using AFNI (effect size is beta values)	10 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Father Flanagan's Boys' Home
• Investigators: Principal Investigator: Nigel Blackwood, MB MD, King's College London

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Oxytocin; Psychopathy; Violent Offenders; Social Processing
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Antisocial Personality Disorder; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 15/LO/1086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This was not built into original ethical protocol due to concerns about sensitivity of data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No