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

Placebo Clinical Trial

— SID  

Official title:

The Role of Stress Neuromodulators in Decision Making Under Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04359147
• Other study ID #: WI-3396-3
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 22, 2021

Study information

• Verified date: March 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: December 22, 2021
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hydrocortisone
• Placebo
• Yohimbine
• Yohimbine + Hydrocortisone

Intervention

Drug:
• "Yohimbine"
Effects on neural correlates of decision-making under risk and selective attention to threat
• "Hydrocortisone"
Effects on neural correlates of decision-making under risk and selective attention to threat
• "Yohimbine + Hydrocortisone"
Effects on neural correlates of decision-making under risk and selective attention to threat
• "Placebo"
Effects on neural correlates of decision-making under risk and selective attention to threat

Locations

Country	Name	City	State
Germany	Charite University	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk and loss-aversion, choice consistency	Behavioural outcome of the decision-making under risk task modeled using prospect theory (PT)	45 minutes
Primary	Patch-leaving times	Behavioural outcome of the decision-making under risk task including a foraging task part using marginal value theory	45 minutes
Primary	Attentional bias to fearful faces	Behavioural outcome of the dot-probe task	12 minutes
Primary	Blood-oxygen-level-dependent (BOLD) response	In both tasks	45 + 12 minutes
Secondary	Salivary cortisol	Treatment check	3 hours
Secondary	Salivary alpha amylase	Treatment check	3 hours
Secondary	Systolic and diastolic blood pressure	Treatment check	3 hours
Secondary	Heart rate	Treatment check	3 hours