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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: ORM-12741
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: High-dosage (60mg), Low-dosage (10mg), Placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dosage (60mg) ORM-12741<br>6 x 10 mg ORM-12741 immediate release capsules in a single dose | Drug: ORM-12741<br>* Novel selective alpha2c adrenoceptor antagonist<br>|
| Experimental: Low-dosage (10mg) ORM-12741<br>1 x 10 mg ORM-12741 immediate release capsules and 5 x placebo capsules in a single dose | Drug: ORM-12741<br>* Novel selective alpha2c adrenoceptor antagonist<br>|
| Placebo Comparator: Placebo<br>6 x placebo capsules in a single dose | Drug: Placebo<br>* Identical in appearance to experimental drug, not psycho-active<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Noradrenalin Agents, Physiological Effects of Drugs, Mood disorders, Behavioral Symptoms