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临床试验/NCT05383300
NCT05383300已完成不适用

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

King's College London1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2017年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Within-group effect of oxytocin on nerual modulation of fear

研究概览

简要总结

A pharmacoimaging study of oxytcoin in antisocial personality disorder and psychopathy

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Double-blinded- participant and investigator.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

Violent offenders with psychopathy

Other

Violent offenders with psychopathy

干预措施: Oxytocin nasal spray (Drug)

Violent offenders with psychopathy

Other

Violent offenders with psychopathy

干预措施: Placebo spray (Other)

Violent offenders without psychopathy

Other

Violent offenders without psychopathy

干预措施: Oxytocin nasal spray (Drug)

Violent offenders without psychopathy

Other

Violent offenders without psychopathy

干预措施: Placebo spray (Other)

Healthy non-offenders

Other

Healthy non-offenders

干预措施: Oxytocin nasal spray (Drug)

Healthy non-offenders

Other

Healthy non-offenders

干预措施: Placebo spray (Other)

结局指标

主要结局

Within-group effect of oxytocin on nerual modulation of fear

时间窗: 10 minutes

Differences in responsivity to morphed faces on FMRI in oxytocin vs fear condition- clusterwise analysis using AFNI (effect size is beta values)

次要结局

  • Baseline neural modulation of morphed fearful faces(10 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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