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Intranasal Oxytocin in Antiosocial Personality Disorder and Psychopathy (OXYASP)

Primary Purpose

Antisocial Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Oxytocin nasal spray
Placebo spray
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Antisocial Personality Disorder focused on measuring Oxytocin; Psychopathy; Violent Offenders; Social Processing

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Insititue of Psychiarty, Psychology and Neuroscience

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Violent offenders with psychopathy

Violent offenders without psychopathy

Healthy non-offenders

Arm Description

Violent offenders with psychopathy

Violent offenders without psychopathy

Healthy non-offenders

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
April 19, 2022
Last Updated
May 16, 2022
Sponsor
King's College London
Collaborators
Father Flanagan's Boys' Home
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1. Study Identification

Unique Protocol Identification Number
NCT05383300
Brief Title
Intranasal Oxytocin in Antiosocial Personality Disorder and Psychopathy
Acronym
OXYASP
Official Title
Investigating the Effect of Oxytocin and the Neurochemistry of Antisocial Personality Disorder and Psychopathy Using Neuroimaging
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
Father Flanagan's Boys' Home

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antisocial Personality Disorder
Keywords
Oxytocin; Psychopathy; Violent Offenders; Social Processing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Double-binded placebo-controlled crossover trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-blinded- participant and investigator.
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Violent offenders with psychopathy
Arm Type
Other
Arm Description
Violent offenders with psychopathy
Arm Title
Violent offenders without psychopathy
Arm Type
Other
Arm Description
Violent offenders without psychopathy
Arm Title
Healthy non-offenders
Arm Type
Other
Arm Description
Healthy non-offenders
Intervention Type
Drug
Intervention Name(s)
Oxytocin nasal spray
Intervention Description
Intranasal spray containing 40 IU of oxytocin
Intervention Type
Other
Intervention Name(s)
Placebo spray
Intervention Description
Application of inert placebo, identical in odor, color, and droplet size except for absence of oxytocin
Primary Outcome Measure Information:
Title
Within-group effect of oxytocin on nerual modulation of fear
Description
Differences in responsivity to morphed faces on FMRI in oxytocin vs fear condition- clusterwise analysis using AFNI (effect size is beta values)
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Baseline neural modulation of morphed fearful faces
Description
Response to morphred faces on FMRI in placebo condition- clusterwise analysis using AFNI (effect size is beta values)
Time Frame
10 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel Blackwood, MB MD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Insititue of Psychiarty, Psychology and Neuroscience
City
London
State/Province
Nottinghamshire
ZIP/Postal Code
SE58AF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This was not built into original ethical protocol due to concerns about sensitivity of data.

Learn more about this trial

Intranasal Oxytocin in Antiosocial Personality Disorder and Psychopathy

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