Intranasal Oxytocin in Antiosocial Personality Disorder and Psychopathy

NCT05383300 | Completed DMC

• 1 other identifier: 15/LO/1086
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

A pharmacoimaging study of oxytcoin in antisocial personality disorder and psychopathy

Conditions

Antisocial Personality Disorder

Keywords

Oxytocin; Psychopathy; Violent Offenders; Social Processing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Baseline neural modulation of morphed fearful faces

  10 minutes

Study Arms (3)

Violent offenders with psychopathy

OTHER

Violent offenders with psychopathy

Drug: Oxytocin nasal spray; Other: Placebo spray

Violent offenders without psychopathy

OTHER

Violent offenders without psychopathy

Drug: Oxytocin nasal spray; Other: Placebo spray

Healthy non-offenders

OTHER

Healthy non-offenders

Drug: Oxytocin nasal spray; Other: Placebo spray

Interventions

Oxytocin nasal spray DRUG

Intranasal spray containing 40 IU of oxytocin

Healthy non-offenders; Violent offenders with psychopathy; Violent offenders without psychopathy

Placebo spray OTHER

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

Healthy non-offenders; Violent offenders with psychopathy; Violent offenders without psychopathy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Father Flanagan's Boys' Home: collaborator

Study Sites (1)

Insititue of Psychiarty, Psychology and Neuroscience

London, Nottinghamshire, SE58AF, United Kingdom

Location

MeSH Terms

Conditions

Antisocial Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Nigel Blackwood, MB MD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded- participant and investigator.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-binded placebo-controlled crossover trial

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 20, 2022
• Study Start: May 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: December 1, 2021
• Last Updated: May 20, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)