The Role of Stress Neuromodulators in Decision Making Under Risk (Part II) (SID2)

The Role of Stress Neuromodulators in Decision Making Under Risk

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.

Study Overview

• Status: Completed
• Conditions: Stress
• Intervention / Treatment: Drug: Placebo; Drug: Clonidin

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katja Wingenfeld; Phone Number: 49-30-450-517534; Email: katja.wingenfeld@charite.de

Study Locations

• Germany
  • Berlin, Germany
    • Charité University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• right handed, high-school diploma

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; placebo pill	Drug: Placebo; placebo pill
Experimental: Clonidin; pill 0,15 mg clonidin	Drug: Clonidin; 0,15mg Clonidin orally versus placebo pill

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	Treatment check	2.5 hours
Heart rate	Treatment check	2.5 hours
salivary cortisol	Treatment check	2.5 hours

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympatholytics; Clonidine
• Other Study ID Numbers: WI 3396-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No