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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT04359147
Collaborator
(none)
167
1
4
25.7
6.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
167 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
The Role of Stress Neuromodulators in Decision Making Under Risk
Actual Study Start Date :
Nov 1, 2019
Actual Primary Completion Date :
Dec 22, 2021
Actual Study Completion Date :
Dec 22, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Yohimbine

10 mg

Drug: "Yohimbine"
Effects on neural correlates of decision-making under risk and selective attention to threat
Other Names:
  • Pill (oral administration)
  • Active Comparator: Hydrocortisone

    10 mg

    Drug: "Hydrocortisone"
    Effects on neural correlates of decision-making under risk and selective attention to threat
    Other Names:
  • Pill (oral administration)
  • Active Comparator: Yohimbine + Hydrocortisone

    10 mg each

    Drug: "Yohimbine + Hydrocortisone"
    Effects on neural correlates of decision-making under risk and selective attention to threat
    Other Names:
  • Pill (oral administration)
  • Placebo Comparator: Placebo

    Drug: "Placebo"
    Effects on neural correlates of decision-making under risk and selective attention to threat
    Other Names:
  • Pill (oral administration)
  • Outcome Measures

    Primary Outcome Measures

    1. Risk and loss-aversion, choice consistency [45 minutes]

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

    2. Patch-leaving times [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 [12 minutes]

      Behavioural outcome of the dot-probe task

    4. Blood-oxygen-level-dependent (BOLD) response [45 + 12 minutes]

      In both tasks

    Secondary Outcome Measures

    1. Salivary cortisol [3 hours]

      Treatment check

    2. Salivary alpha amylase [3 hours]

      Treatment check

    3. Systolic and diastolic blood pressure [3 hours]

      Treatment check

    4. Heart rate [3 hours]

      Treatment check

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charite University Berlin Germany

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Katja Wingenfeld, Principal Investigator, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT04359147
    Other Study ID Numbers:
    • WI-3396-3
    First Posted:
    Apr 24, 2020
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 15, 2022