The Role of Stress Neuromodulators in Decision Making Under Risk and Selective Attention to Threat
SID
1 other identifier
interventional
167
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 20, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2021
CompletedMarch 15, 2022
March 1, 2022
2.1 years
April 20, 2020
March 14, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Risk and loss-aversion, choice consistency
Behavioural outcome of the decision-making under risk task modeled using prospect theory (PT)
45 minutes
Patch-leaving times
Behavioural outcome of the decision-making under risk task including a foraging task part using marginal value theory
45 minutes
Attentional bias to fearful faces
Behavioural outcome of the dot-probe task
12 minutes
Blood-oxygen-level-dependent (BOLD) response
In both tasks
45 + 12 minutes
Secondary Outcomes (4)
Salivary cortisol
3 hours
Salivary alpha amylase
3 hours
Systolic and diastolic blood pressure
3 hours
Heart rate
3 hours
Study Arms (4)
Yohimbine
ACTIVE COMPARATOR10 mg
Hydrocortisone
ACTIVE COMPARATOR10 mg
Yohimbine + Hydrocortisone
ACTIVE COMPARATOR10 mg each
Placebo
PLACEBO COMPARATORInterventions
Effects on neural correlates of decision-making under risk and selective attention to threat
Effects on neural correlates of decision-making under risk and selective attention to threat
Effects on neural correlates of decision-making under risk and selective attention to threat
Effects on neural correlates of decision-making under risk and selective attention to threat
Eligibility Criteria
You may qualify if:
- Right-handed
- High-school diploma
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charite University
Berlin, Germany
Related Publications (1)
Rosada C, Lipka R, Metz S, Otte C, Heekeren H, Wingenfeld K. Effects of stress-related neuromodulators on amygdala and hippocampus resting state functional connectivity. J Psychopharmacol. 2024 Jul;38(7):604-614. doi: 10.1177/02698811241260972. Epub 2024 Jun 20.
PMID: 38902928DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 20, 2020
First Posted
April 24, 2020
Study Start
November 1, 2019
Primary Completion
December 22, 2021
Study Completion
December 22, 2021
Last Updated
March 15, 2022
Record last verified: 2022-03