Single-dose Novel Selective alpha2c Antagonist Pharmaco-MRI Study in Healthy Volunteers

The Effects of Single-dose Administration of a Novel Selective alpha2c Antagonist on Emotional and Cognitive Processing in Healthy Volunteers: an fMRI Investigation

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03440021

Acronym

SNAP_MRI

Enrollment

Registered

2018-02-20

Start date

2018-03-26

Completion date

2018-12-06

Last updated

2019-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Noradrenalin Agents, Physiological Effects of Drugs, Mood disorders, Behavioral Symptoms

Brief summary

The aim of the present study is to investigate changes in neural activity (BOLD signal), as measured using fMRI, in brain areas associated with emotional and working memory during task performance after single-dose administration of a novel selective alpha2c adrenoceptor antagonist (ORM-12741) in healthy volunteers. Further, it will be explored whether ORM-12741 affects connectivity between brain areas in rest, as measured using fMRI, and cognitive performance in the sample under investigation.

Interventions

DRUGORM-12741

Novel selective alpha2c adrenoceptor antagonist

DRUGPlacebo

Identical in appearance to experimental drug, not psycho-active

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Intervention model description

High-dosage (60mg), Low-dosage (10mg), Placebo

Eligibility

Sex/Gender

ALL

Age

18 Years to 30 Years

Healthy volunteers

Yes

Inclusion criteria

* good command of English language * right handedness * normal or corrected-to-normal vision

Exclusion criteria

* personal history or active presence of psychiatric conditions * usage of psychotropic medication within the past 3 months * pregnancy or breast-feeding status * systolic blood pressure \< 90 mmHg or \> 140 mmHg at screening visit * diastolic blood pressure \< 50 mmHg or \> 90 mmHg at screening visit * resting heart rate \< 45 beats/minute or \> 100 beats/minute at screening visit * active presence of medical condition at physical examination * history of major traumatic brain injury * any other contraindication to MRI of the brain * use of psychoactive substances incl. alcohol in 24 hours prior to test session

Design outcomes

Primary

Measure	Time frame
Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with emotional memory	1-1.5 hours post medication intake
Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with working memory	1-1.5 hours post medication intake

Secondary

Measure	Time frame
Effect of ORM-12741 on connectivity measures between brain areas as measured with BOLD signal in fMRI obtained in a resting state	1.5-2 hours post medication intake
Effect of ORM-12741 on memory task performance (as measured by accuracy and response latency)	1-3 hours post medication intake

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026