Antisocial Personality DisorderOXYASPNCT05383300
Intranasal Oxytocin in Antiosocial Personality Disorder and Psychopathy
A study testing Oxytocin nasal spray in people with Antisocial Personality Disorder, run by King's College London at 1 site in United Kingdom.
Trial summary
A pharmacoimaging study of oxytcoin in antisocial personality disorder and psychopathy Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Antisocial Personality Disorder
- What is being tested?
- Oxytocin nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2017to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Insititue of Psychiarty, Psychology and Neuroscience
London, Nottinghamshire, SE58AF
About this study
Official title: 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
Read the 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).
- Conditions
- Antisocial Personality Disorder
- Being tested
- Oxytocin nasal spray, Placebo spray
- Keywords
- Oxytocin; Psychopathy; Violent Offenders; Social Processing
- Medical subject headings
- Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
Intranasal spray containing 40 IU of oxytocin
Placebo sprayOther
Application of inert placebo, identical in odor, color, and droplet size except for absence of oxytocin
| Study group | Role | What they receive |
|---|---|---|
| Violent offenders with psychopathy | Other | Violent offenders with psychopathy Receives: Drug: Oxytocin nasal spray; Other: Placebo spray |
| Violent offenders without psychopathy | Other | Violent offenders without psychopathy Receives: Drug: Oxytocin nasal spray; Other: Placebo spray |
| Healthy non-offenders | Other | Healthy non-offenders Receives: Drug: Oxytocin nasal spray; Other: Placebo spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 10 minutes
Secondary outcomes (1)
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)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start1 May 2017
- Primary completion1 Mar 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antisocial Personality DisorderStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-binded placebo-controlled crossover trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Father Flanagan's Boys' Home
- Responsible party
- Sponsor
- Investigators
- Nigel Blackwood, MB MD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383300
- Sponsor's protocol ID
- 15/LO/1086
- Acronym
- OXYASP
- Status last verified
- Dec 2021
- First submitted
- 19 Apr 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This was not built into original ethical protocol due to concerns about sensitivity of data.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Oxytocin and the Neurochemistry of Antisocial Personality Disorder and Psychopathy Using Neuroimaging
- ClinicalTrials.gov ID
- NCT05383300
- Acronym / sponsor ID
- OXYASP / 15/LO/1086
- Conditions
- Antisocial Personality Disorder
- Keywords
- Oxytocin; Psychopathy; Violent Offenders; Social Processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Father Flanagan's Boys' Home
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Double-binded placebo-controlled crossover trial
| Arm | Type | Receives |
|---|---|---|
| Violent offenders with psychopathy | Other | Drug: Oxytocin nasal spray, Other: Placebo sprayViolent offenders with psychopathy |
| Violent offenders without psychopathy | Other | Drug: Oxytocin nasal spray, Other: Placebo sprayViolent offenders without psychopathy |
| Healthy non-offenders | Other | Drug: Oxytocin nasal spray, Other: Placebo sprayHealthy non-offenders |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male
- Aged 18-60
- IQ greater than 70 as defined by the Wechsler Abbreviated Scale of Intelligence (WASI-II).
- 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.
- Non-offenders with no personality disorder
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin nasal sprayIntranasal spray containing 40 IU of oxytocin | Drug | Healthy non-offenders, Violent offenders with psychopathy, Violent offenders without psychopathy |
| Placebo sprayApplication of inert placebo, identical in odor, color, and droplet size except for absence of oxytocin | Other | Healthy non-offenders, Violent offenders with psychopathy, Violent offenders without psychopathy |
Primary outcome
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)
1 secondary outcome
Baseline neural modulation of morphed fearful faces
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Individual participant dataSharing planned: No. This was not built into original ethical protocol due to concerns about sensitivity of data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nigel Blackwood, MB MD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin nasal spray in people with Antisocial Personality Disorder, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-group effect of oxytocin on nerual modulation of fear (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.