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

Not Applicable

Completed

• Conditions: Stress
• Interventions: Drug: Clonidin; Drug: Placebo

• Registration Number: NCT05318248
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-31
• Study First Posted: 2022-04-08
• Status Verified: 2023-03
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 82

Inclusion Criteria

• right handed, high-school diploma

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clonidin	Clonidin	pill 0,15 mg clonidin
Placebo	Placebo	placebo pill

Primary Outcome Measures

Name	Time	Method
Working Memory (n-back task)	11 minutes	Behavioral outcome of emotional two-back task = number of correct answers / button presses
Recognition Memory (word list learning)	25 minutes	Behavioral outcome of word recognition task = number of correctly recognized words
Blood-oxygen-level-dependent (BOLD) response	46 minutes	fMRI data

Secondary Outcome Measures

Name	Time	Method
blood pressure	2.5 hours	Treatment check
Heart rate	2.5 hours	Treatment check
salivary cortisol	2.5 hours	Treatment check

Trial Locations

Locations (1)

Charite University; 🇩🇪 Berlin, Germany