CClinicalTrials.gg
CompletedNCT04359147SIDUpdated Mar 15, 2022

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

An interventional study of "Yohimbine" and "Hydrocortisone" in Yohimbine, Hydrocortisone and Yohimbine + Hydrocortisone, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-15.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2019, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
167
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Yohimbine
  • Hydrocortisone
  • Yohimbine + Hydrocortisone
  • Placebo
03

In context

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Right-handed
  • High-school diploma

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
167 participants (actual)

Study arms

  • Active comparator
    Yohimbine

    10 mg

    Drug: "Yohimbine"

  • Active comparator
    Hydrocortisone

    10 mg

    Drug: "Hydrocortisone"

  • Active comparator
    Yohimbine + Hydrocortisone

    10 mg each

    Drug: "Yohimbine + Hydrocortisone"

  • Placebo comparator
    Placebo

    Drug: "Placebo"

Interventions

  • Drug"Yohimbine"

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

    Also known as: Pill (oral administration)

  • Drug"Hydrocortisone"

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

    Also known as: Pill (oral administration)

  • Drug"Yohimbine + Hydrocortisone"

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

    Also known as: Pill (oral administration)

  • Drug"Placebo"

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

    Also known as: Pill (oral administration)

06

What researchers measure

Primary outcomes

  1. Risk and loss-aversion, choice consistency

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

    Time frame: 45 minutes

  2. Patch-leaving times

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

    Time frame: 45 minutes

  3. Attentional bias to fearful faces

    Behavioural outcome of the dot-probe task

    Time frame: 12 minutes

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

    In both tasks

    Time frame: 45 + 12 minutes

Secondary outcomes

  1. Salivary cortisol

    Treatment check

    Time frame: 3 hours

  2. Salivary alpha amylase

    Treatment check

    Time frame: 3 hours

  3. Systolic and diastolic blood pressure

    Treatment check

    Time frame: 3 hours

  4. Heart rate

    Treatment check

    Time frame: 3 hours

07

Study locations

1 site
  • Charite University
    Berlin, Germany
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04359147
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Katja Wingenfeld (Principal Investigator, Charite University, Berlin, Germany) — Principal investigator
First posted
Apr 24, 2020
Start date
Nov 1, 2019
Primary completion
Dec 22, 2021
Completion
Dec 22, 2021
Last update
Mar 15, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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