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临床试验/NCT03829839
NCT03829839已完成1 期

Common and Dissociable Effects of Oxytocin and Lorazepam on the Neurocircuitry of Fear - an Ultra-high Field Imaging Study

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年3月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Neural responses to emotional faces in the amygdala subregions

研究概览

简要总结

High-potency benzodiazepines have strong anxiolytic effects accompanied by significant adverse effects including impaired cognitive function, drowsiness, dizziness and impaired motoric abilities. Importantly, the long-term use of benzodiazepines may produce dependence and withdrawal. Therefore, there is considerable scientific and public interest in identifying new anxiolytic agents.

The hypothalamic peptide oxytocin (OXT) has anxiolytic effects both in healthy participants and patients with anxiety disorders by decreasing fear-associated amygdala activity. However, so far no human study has directly compared the underlying anxiolytic mechanisms of OXT and established anxiolytic agents on amygdala activity. Importantly, the amygdala is not a homogenous structure but rather consists of several subdivisions with structural and functional differences.

Therefore, the rationale of the present project is to determine the effects of intranasal OXT and the high-potency benzodiazepine lorazepam on fear-associated responses in intra-amygdalar subregions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • healthy male volunteers
  • right-handed

排除标准

  • Current or past psychiatric illness
  • Current or past physical illness
  • Psychoactive medication
  • Sedative medication
  • MRI contraindication (e.g. metal in body, claustrophobia)

研究组 & 干预措施

Lorazepam or PLC

Active Comparator

Single dose of lorazepam (1mg) or PLC

干预措施: Lorazepam 1 mg (Drug)

Oxytocin or PLC

Active Comparator

Single dose of intranasal oxytocin (24 international units) or PLC.

干预措施: Oxytocin (Drug)

Oxytocin or PLC

Active Comparator

Single dose of intranasal oxytocin (24 international units) or PLC.

干预措施: Placebo nasalspray (Drug)

Lorazepam or PLC

Active Comparator

Single dose of lorazepam (1mg) or PLC

干预措施: Placebo Oral Tablet (Drug)

结局指标

主要结局

Neural responses to emotional faces in the amygdala subregions

时间窗: Neural activations with be measured with 7 Tesla fMRI in an emotional face matching task that lasts 20 mins

Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate amygdala subregion responses to emotional faces.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rene Hurlemann

Vice Chair of the Department of Psychiatry and Chair of the Medical Psychology Division

University Hospital, Bonn

研究点 (1)

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