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临床试验/NCT03846739
NCT03846739已完成1 期

Dose-dependent Effects of Oxytocin on the Amygdala and Reward System Vary Between Women and Men

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2017年4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
92
试验地点
1
主要终点
Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala

研究概览

简要总结

The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala and reward system responses vary as a function of treatment dose in women in comparison to men.

详细描述

The objective of the present study is to determine whether intranasal oxytocin (IN-OXT) effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD fMRI) in the amygdala and striatal regions (putamen, nucleus accumbens, caudate, pallidum) vary as a function of dose. In particular, the investigators plan to compare effects of three different IN-OXT doses (6, 12, and 24 international units, IU) on established neural and behavioural correlates of emotion processing in women. Results will be discussed in comparison to a previous study of OXT kinetics in men.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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
Female
接受健康志愿者

入选标准

  • Healthy female volunteers
  • Right-handed
  • Non-smoker

排除标准

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

研究组 & 干预措施

Oxytocin & Placebo, 6 IU

Active Comparator

Intranasal administration, 6 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.

干预措施: Oxytocin nasal spray (Drug)

Oxytocin & Placebo, 6 IU

Active Comparator

Intranasal administration, 6 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.

干预措施: Placebo (Drug)

Oxytocin & Placebo, 12 IU

Active Comparator

Intranasal administration,12 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.

干预措施: Oxytocin nasal spray (Drug)

Oxytocin & Placebo, 12 IU

Active Comparator

Intranasal administration,12 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.

干预措施: Placebo (Drug)

Oxytocin & Placebo, 24 IU

Active Comparator

Intranasal administration, 24 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.

干预措施: Oxytocin nasal spray (Drug)

Oxytocin & Placebo, 24 IU

Active Comparator

Intranasal administration, 24 IU oxytocin nasal spray or placebo. Imaging starting 45 min after nasal spray administration.

干预措施: Placebo (Drug)

结局指标

主要结局

Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala

时间窗: 45 min after nasal spray administration

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 responses to emotional faces, because previous studies found sex-specific effects of oxytocin on amygdala activation.

Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in striatal regions (putamen, nucleus accumbens, caudate, pallidum)

时间窗: 45 min after nasal spray administration

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 striatal responses to emotional faces to explore sex-specific effects of OXT on reward-related brain activation.

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

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

University Hospital, Bonn

研究点 (1)

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