The Role of Stress Neuromodulators in Decision Making Under Risk (Part II)

Stress Clinical Trial

— SID2  

Official title:

The Role of Stress Neuromodulators in Decision Making Under Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318248
• Other study ID #: WI 3396-11
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: March 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the proposed project is to combine precise pharmacological manipulation of the noradrenergic system with behavioral modeling of memory processes, and fMRI methods to study the effect of a pharmacologically induced blockade of the noradrenergic system on memory processes. Behaviorally, the investigators will focus on the effect of the noradrenergic blockade on working memory performance, and recognition memory.

Description:

Affective states like acute stress can influence cognition, i.e., memory processes. Physiologically, acute stress elicits an array of autonomic and endocrine responses, including a fast release of norepinephrine from the locus coeruleus noradrenergic (LC NA) system. Compelling evidence shows that in healthy humans, stimulation of the noradrenergic system increases memory performance whereas noradrenergic blockade reduces memory performance. Functional magnetic resonance imaging (fMRI) studies have shown that manipulations of the noradrenergic system affects responsiveness and connectivity within networks that are important for autonomic-neuroendocrine control and temporal and spatial attention orientation. So far, no study investigated the neural underpinnings of memory processes after a pharmacologically induced noradrenergic blockade. The aim of the proposed project is to combine precise pharmacological manipulation of the noradrenergic system with behavioral modeling of distinct memory processes, and fMRI methods to study the effect of a pharmacologically induced blockade of the noradrenergic system on two distinct memory processes. Behaviorally, the investigators will focus on the effect of the noradrenergic blockade on working memory performance, and recognition memory. Participants are randomly assigned to one of two groups: (A) clonidine, or (B) placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• right handed, high-school diploma

Exclusion Criteria:

• former & present DSM-5 axis I disorders, medication,

Related Conditions & MeSH terms

• Stress

Intervention

Drug:
• Clonidin
0,15mg Clonidin orally versus placebo pill
• Placebo
placebo pill

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	Working Memory (n-back task)	Behavioral outcome of emotional two-back task = number of correct answers / button presses	11 minutes
Primary	Recognition Memory (word list learning)	Behavioral outcome of word recognition task = number of correctly recognized words	25 minutes
Primary	Blood-oxygen-level-dependent (BOLD) response	fMRI data	46 minutes
Secondary	blood pressure	Treatment check	2.5 hours
Secondary	Heart rate	Treatment check	2.5 hours
Secondary	salivary cortisol	Treatment check	2.5 hours