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临床试验/NCT04359147
NCT04359147已完成不适用

The Role of Stress Neuromodulators in Decision Making Under Risk

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2019年11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
167
试验地点
1
主要终点
Risk and loss-aversion, choice consistency

研究概览

简要总结

Incidental affective states, i.e., affective states can influence decision making and selective attention to threatening information. Acute stress is such an affective state and is a powerful contextual modulator of decision-making processes and selective attention to threat. In terms of physiological and neurohormonal changes, the stress response has been well characterized: Exposure to stress elicits an array of autonomic, endocrine, and behavioral responses. The physiological stress response is mediated by the hypothalamic-pituitary-adrenal (HPA) axis and the locus coeruleus noradrenergic (LC-NA) system with cortisol and norepinephrine (NE) as their end products. There is compelling evidence that the stress hormones cortisol and NE influence cognitive processes. However, only very few studies so far used pharmacological approaches to specify the role of stress neuromodulators on decision making and selective attention to threat and these studies are hardly comparable due to differences in the experimental design, e.g., the decision making task used. Furthermore, the neural underpinnings of stress effects on decision making and selective attention to threat are uninvestigated so far. The aim of the proposed project is to clarify the role of the major stress neuromodulators, NE and cortisol, in their contribution to different processes related to decision making under risk and selective attention to threat. To this end, combined precise pharmacological stimulation, behavioral modeling, and fMRI methods will be applied to systematically disentangle the effects of stress hormones on risk attitudes and loss aversion as well as their relation to neural correlates of processing subjective value and risk. Using pharmacological manipulation, the influence of noradrenergic and glucocorticoid activity on decision making under risk at the behavioral, computational, and neural level will be investigated. In addition, the influence of noradrenergic and glucocorticoid activity on selective attention to threat at the behavioural and neural level using a dot-probe paradigm with fearful and neutral faces will be examined. Participants are randomly assigned to one of four groups: (A) yohimbine, (B) hydrocortisone, (C) yohimbine and hydrocortisone, or (D) placebo.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Right-handed
  • High-school diploma

排除标准

  • Former and present DSM-5 axis I disorders according to the Structured Clinical Interview for DSM (SCID)
  • Permanent medication of any kind
  • Medical conditions associated with adrenal dysfunction or well-known impact on HPA activity or cognitive function
  • Steroid use

研究组 & 干预措施

Yohimbine

Active Comparator

10 mg

干预措施: "Yohimbine" (Drug)

Hydrocortisone

Active Comparator

10 mg

干预措施: "Hydrocortisone" (Drug)

Yohimbine + Hydrocortisone

Active Comparator

10 mg each

干预措施: "Yohimbine + Hydrocortisone" (Drug)

Placebo

Placebo Comparator

干预措施: "Placebo" (Drug)

结局指标

主要结局

Risk and loss-aversion, choice consistency

时间窗: 45 minutes

Behavioural outcome of the decision-making under risk task modeled using prospect theory (PT)

Patch-leaving times

时间窗: 45 minutes

Behavioural outcome of the decision-making under risk task including a foraging task part using marginal value theory

Attentional bias to fearful faces

时间窗: 12 minutes

Behavioural outcome of the dot-probe task

Blood-oxygen-level-dependent (BOLD) response

时间窗: 45 + 12 minutes

In both tasks

次要结局

  • Salivary alpha amylase(3 hours)
  • Systolic and diastolic blood pressure(3 hours)
  • Heart rate(3 hours)
  • Salivary cortisol(3 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katja Wingenfeld

Principal Investigator

Charite University, Berlin, Germany

研究点 (1)

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