Intranasal Oxytocin in Antiosocial Personality Disorder and Psychopathy (OXYASP)
May 16, 2022 updated by: King's College London
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nottinghamshire
-
London, Nottinghamshire, United Kingdom, SE58AF
- Insititue of Psychiarty, Psychology and Neuroscience
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 56 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Violent offenders with psychopathy
|
Intranasal spray containing 40 IU of oxytocin
Application of inert placebo, identical in odor, color, and droplet size except for absence of oxytocin
|
|
Other: Violent offenders without psychopathy
|
Intranasal spray containing 40 IU of oxytocin
Application of inert placebo, identical in odor, color, and droplet size except for absence of oxytocin
|
|
Other: Healthy non-offenders
|
Intranasal spray containing 40 IU of oxytocin
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
Time Frame: 10 minutes
|
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
Time Frame: 10 minutes
|
Response to morphred faces on FMRI in placebo condition- clusterwise analysis using AFNI (effect size is beta values)
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nigel Blackwood, MB MD, King's College London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.