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| ID | Type | Description | Link |
|---|---|---|---|
| N2/19/8/2 | Other Identifier | MCC South Africa | |
| DOH-27-0218-5843 | Registry Identifier | SANCTR |
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| Name | Class |
|---|---|
| Orion Corporation, Orion Pharma | INDUSTRY |
| University of Oxford | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dosage (60mg) ORM-12741 | Experimental | 6 x 10 mg ORM-12741 immediate release capsules in a single dose |
|
| Low-dosage (10mg) ORM-12741 | Experimental | 1 x 10 mg ORM-12741 immediate release capsules and 5 x placebo capsules in a single dose |
|
| Placebo | Placebo Comparator | 6 x placebo capsules in a single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORM-12741 | Drug | Novel selective alpha2c adrenoceptor antagonist |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan J. Stein, MD, PhD | University of Cape Town | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCT Dept. Psychiatry & Mental Health / CUBIC | Cape Town | Western Cape | 7925 | South Africa |
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001526 | Behavioral Symptoms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000588919 | ORM-12741 |
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High-dosage (60mg), Low-dosage (10mg), Placebo
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| Placebo | Drug | Identical in appearance to experimental drug, not psycho-active |
|
| 1-3 hours post medication intake |