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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Recruiting

CT.gov ID

NCT05318248

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress	Drug: Clonidin Drug: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

The Role of Stress Neuromodulators in Decision Making Under Risk

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Clonidin

pill 0,15 mg clonidin

Drug: Clonidin

0,15mg Clonidin orally versus placebo pill

Placebo Comparator: Placebo

placebo pill

Drug: Placebo

placebo pill

Outcome Measures

Primary Outcome Measures

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

blood pressure [2.5 hours]
Treatment check
Heart rate [2.5 hours]
Treatment check
salivary cortisol [2.5 hours]
Treatment check

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

right handed, high-school diploma

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charite University	Berlin		Germany

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katja Wingenfeld, Prof. Dr., Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT05318248

Other Study ID Numbers:

WI 3396-11

First Posted:

Apr 8, 2022

Last Update Posted:

Apr 8, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Clonidine

Study Results

No Results Posted as of Apr 8, 2022