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Completed

NCT Number: NCT04359147

The Role of Stress Neuromodulators in Decision Making Under Risk and Selective Attention to Threat

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Charite University

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Right-handed
  • High-school diploma

Exclusion criteria

  • 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

Treatment and study plan

"Yohimbine"

Drug

Effects on neural correlates of decision-making under risk and selective attention to threat

Other names: Pill (oral administration)

"Hydrocortisone"

Drug

Effects on neural correlates of decision-making under risk and selective attention to threat

Other names: Pill (oral administration)

"Yohimbine + Hydrocortisone"

Drug

Effects on neural correlates of decision-making under risk and selective attention to threat

Other names: Pill (oral administration)

"Placebo"

Drug

Effects on neural correlates of decision-making under risk and selective attention to threat

Other names: Pill (oral administration)

Primary outcomes

  1. Risk and loss-aversion, choice consistency

    Time frame: 45 minutes

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

  2. Patch-leaving times

    Time frame: 45 minutes

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

  3. Attentional bias to fearful faces

    Time frame: 12 minutes

    Behavioural outcome of the dot-probe task

  4. Blood-oxygen-level-dependent (BOLD) response

    Time frame: 45 + 12 minutes

    In both tasks

Secondary outcomes

  1. Salivary cortisol

    Time frame: 3 hours

    Treatment check

  2. Salivary alpha amylase

    Time frame: 3 hours

    Treatment check

  3. Systolic and diastolic blood pressure

    Time frame: 3 hours

    Treatment check

  4. Heart rate

    Time frame: 3 hours

    Treatment check

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

The Role of Stress Neuromodulators in Decision Making Under Risk

Acronym: SID

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2020
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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