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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2018-12-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Single-dose of Nalmefene to Modulate Neural Alcohol Cue Reactivity

NCT02372318

Alcoholism

TERMINATED EARLY_PHASE1

Vasopressin and Pain Perception in the Brain

NCT03446456

Acute Pain

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

The Effect of Losartan on Emotional Processing in Healthy Volunteers

NCT03434054

Healthy Volunteers

COMPLETED NA

Control of Cognition (Naltrexone, Methylphenidate, and ADHD Study (NMAS))

NCT01993108

Healthy Attention Deficit Hyperactivity Disorder

COMPLETED PHASE4

Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication

NCT00388414

Low Back Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High-dosage (60mg) ORM-12741

6 x 10 mg ORM-12741 immediate release capsules in a single dose

Group Type EXPERIMENTAL

ORM-12741

Intervention Type DRUG

Novel selective alpha2c adrenoceptor antagonist

Low-dosage (10mg) ORM-12741

1 x 10 mg ORM-12741 immediate release capsules and 5 x placebo capsules in a single dose

Group Type EXPERIMENTAL

ORM-12741

Intervention Type DRUG

Novel selective alpha2c adrenoceptor antagonist

Placebo

6 x placebo capsules in a single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Identical in appearance to experimental drug, not psycho-active

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ORM-12741

Novel selective alpha2c adrenoceptor antagonist

Intervention Type DRUG

Placebo

Identical in appearance to experimental drug, not psycho-active

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes