Intranasal Oxytocin in Antiosocial Personality Disorder and Psychopathy

Antisocial Personality Disorder Clinical Trial

— OXYASP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05383300
• Other study ID #: 15/LO/1086
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A pharmacoimaging study of oxytcoin in antisocial personality disorder and psychopathy

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 1, 2021
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Antisocial Personality Disorder
• Personality Disorders

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Insititue of Psychiarty, Psychology and Neuroscience	London	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Father Flanagan's Boys' Home

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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