YohimbineSIDNCT04359147
The Role of Stress Neuromodulators in Decision Making Under Risk and Selective Attention to Threat
A study testing "Yohimbine", "Hydrocortisone" and "Yohimbine + Hydrocortisone" in people with Yohimbine and Hydrocortisone, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Yohimbine, Hydrocortisone, Yohimbine + Hydrocortisone
- What is being tested?
- "Yohimbine", "Hydrocortisone" and "Yohimbine + Hydrocortisone"
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2019to 22 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handed
- High-school diploma
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Stress Neuromodulators in Decision Making Under Risk
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.
- Conditions
- Yohimbine, Hydrocortisone, Yohimbine + Hydrocortisone, Placebo
- Being tested
- "Yohimbine", "Hydrocortisone", "Yohimbine + Hydrocortisone", "Placebo"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Yohimbine"Drug
Also called Pill (oral administration)
Effects on neural correlates of decision-making under risk and selective attention to threat
"Hydrocortisone"Drug
Also called Pill (oral administration)
Effects on neural correlates of decision-making under risk and selective attention to threat
"Yohimbine + Hydrocortisone"Drug
Also called Pill (oral administration)
Effects on neural correlates of decision-making under risk and selective attention to threat
"Placebo"Drug
Also called Pill (oral administration)
Effects on neural correlates of decision-making under risk and selective attention to threat
| Study group | Role | What they receive |
|---|---|---|
| Yohimbine | Active comparator | 10 mg Receives: Drug: "Yohimbine" |
| Hydrocortisone | Active comparator | 10 mg Receives: Drug: "Hydrocortisone" |
| Yohimbine + Hydrocortisone | Active comparator | 10 mg each Receives: Drug: "Yohimbine + Hydrocortisone" |
| Placebo | Placebo comparator | Not described Receives: Drug: "Placebo" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk and loss-aversion, choice consistency
Behavioural outcome of the decision-making under risk task modeled using prospect theory (PT)
Measured: 45 minutes
Patch-leaving times
Behavioural outcome of the decision-making under risk task including a foraging task part using marginal value theory
Measured: 45 minutes
Attentional bias to fearful faces
Behavioural outcome of the dot-probe task
Measured: 12 minutes
Blood-oxygen-level-dependent (BOLD) response
In both tasks
Measured: 45 + 12 minutes
Secondary outcomes (4)
Salivary cortisol
Treatment check
Measured: 3 hours
Salivary alpha amylase
Treatment check
Measured: 3 hours
Systolic and diastolic blood pressure
Treatment check
Measured: 3 hours
Heart rate
Treatment check
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Nov 2019
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for YohimbineStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katja Wingenfeld, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359147
- Sponsor's protocol ID
- WI-3396-3
- Acronym
- SID
- Status last verified
- Mar 2022
- First submitted
- 20 Apr 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38902928Metz S, Mengering L, Lipka R, Rosada C, Otte C, Heekeren H, Wingenfeld K. The effects of yohimbine and hydrocortisone on selective attention to fearful faces: An fMRI study. Psychoneuroendocrinology. 2024 Jul;165:107031. doi: 10.1016/j.psyneuen.2024.107031. Epub 2024 Mar 21.
PubMed 38581746
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Stress Neuromodulators in Decision Making Under Risk
- ClinicalTrials.gov ID
- NCT04359147
- Acronym / sponsor ID
- SID / WI-3396-3
- Conditions
- Yohimbine, Hydrocortisone, Yohimbine + Hydrocortisone, Placebo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Yohimbine | Active comparator | Drug: "Yohimbine"10 mg |
| Hydrocortisone | Active comparator | Drug: "Hydrocortisone"10 mg |
| Yohimbine + Hydrocortisone | Active comparator | Drug: "Yohimbine + Hydrocortisone"10 mg each |
| Placebo | Placebo comparator | Drug: "Placebo" |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Right-handed
- High-school diploma
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Yohimbine"Also: Pill (oral administration)Effects on neural correlates of decision-making under risk and selective attention to threat | Drug | Yohimbine |
| "Hydrocortisone"Also: Pill (oral administration)Effects on neural correlates of decision-making under risk and selective attention to threat | Drug | Hydrocortisone |
| "Yohimbine + Hydrocortisone"Also: Pill (oral administration)Effects on neural correlates of decision-making under risk and selective attention to threat | Drug | Yohimbine + Hydrocortisone |
| "Placebo"Also: Pill (oral administration)Effects on neural correlates of decision-making under risk and selective attention to threat | Drug | Placebo |
Primary outcome
Risk and loss-aversion, choice consistency
Time frame: 45 minutes
Behavioural outcome of the decision-making under risk task modeled using prospect theory (PT)
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
Attentional bias to fearful faces
Time frame: 12 minutes
Behavioural outcome of the dot-probe task
Blood-oxygen-level-dependent (BOLD) response
Time frame: 45 + 12 minutes
In both tasks
4 secondary outcomes
Salivary cortisol
Time frame: 3 hours
Salivary alpha amylase
Time frame: 3 hours
Systolic and diastolic blood pressure
Time frame: 3 hours
Heart rate
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Derived from this study: PubMed 38902928Rosada 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.
- Derived from this study: PubMed 38581746Metz S, Mengering L, Lipka R, Rosada C, Otte C, Heekeren H, Wingenfeld K. The effects of yohimbine and hydrocortisone on selective attention to fearful faces: An fMRI study. Psychoneuroendocrinology. 2024 Jul;165:107031. doi: 10.1016/j.psyneuen.2024.107031. Epub 2024 Mar 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Yohimbine", "Hydrocortisone" and "Yohimbine + Hydrocortisone" in people with Yohimbine and Hydrocortisone, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk and loss-aversion, choice consistency (time frame: 45 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359147, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.