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

NCT ID: NCT05318248

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-03-31

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.

Conditions

Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Clonidin

pill 0,15 mg clonidin

Group Type: EXPERIMENTAL

Clonidin

Intervention Type: DRUG

0,15mg Clonidin orally versus placebo pill

Placebo

placebo pill

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo pill

Interventions

Clonidin

0,15mg Clonidin orally versus placebo pill

Intervention Type: DRUG

Placebo

placebo pill

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• right handed, high-school diploma

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Katja Wingenfeld

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charite University

Berlin, , Germany

Countries

Germany

Other Identifiers

WI 3396-11

Identifier Type: -

Identifier Source: org_study_id