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OpenTrials
Completed

NCT Number: NCT05318248

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Charite University

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • right handed, high-school diploma

Exclusion criteria

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

Treatment and study plan

Clonidin

Drug

0,15mg Clonidin orally versus placebo pill

Placebo

Drug

placebo pill

Primary outcomes

  1. Working Memory (n-back task)

    Time frame: 11 minutes

    Behavioral outcome of emotional two-back task = number of correct answers / button presses

  2. Recognition Memory (word list learning)

    Time frame: 25 minutes

    Behavioral outcome of word recognition task = number of correctly recognized words

  3. Blood-oxygen-level-dependent (BOLD) response

    Time frame: 46 minutes

    fMRI data

Secondary outcomes

  1. blood pressure

    Time frame: 2.5 hours

    Treatment check

  2. Heart rate

    Time frame: 2.5 hours

    Treatment check

  3. salivary cortisol

    Time frame: 2.5 hours

    Treatment check

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

The Role of Stress Neuromodulators in Decision Making Under Risk

Acronym: SID2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2022
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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