NCT05318248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

March 16, 2022

Last Update Submit

March 31, 2023

Conditions

Stress

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • blood pressure

    2.5 hours

  • Heart rate

    2.5 hours

  • salivary cortisol

    2.5 hours

Study Arms (2)

Clonidin

EXPERIMENTAL

pill 0,15 mg clonidin

Drug: Clonidin

Placebo

PLACEBO COMPARATOR

placebo pill

Drug: Placebo

Interventions

ClonidinDRUG

0,15mg Clonidin orally versus placebo pill

Clonidin
PlaceboDRUG

placebo pill

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • right handed, high-school diploma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University

Berlin, Germany

Location

MeSH Terms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 16, 2022

First Posted

April 8, 2022

Study Start

March 1, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Locations

DE(1)