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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001839-23 | EudraCT Number |
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The purpose of this study is to determine if Vortioxetine 20 mg/day will lead to changes in neural activity (BOLD signal), as measured using fMRI, in brain areas associated with executive functioning and memory during cognitive task performances compared to placebo in subjects remitted from depression and in controls, and to explore if Vortioxetine will lead to improved cognitive performance in the absence of depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine (Lu AA21004) | Drug | encapsulated 20 mg tablets, orally, once daily for 13 to 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with executive function (working memory) | Day 1 to Day 13 | |
| Effect of Vortioxetine on BOLD signal in fMRI of the brain areas associated with spatial memory | Day 1 to Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Vortioxetine on cognitive performance (executive function, memory, speed of processing, attention, cognitive flexibility) and emotional processing | Day 1 to Day 13 |
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Inclusion Criteria:
All subjects must have:
Subjects remitted from depression must:
Control group subjects must:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GB001 | Headington | OX3 7JX | United Kingdom |
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| Placebo | Drug | capsules, orally, once daily for 13 to 14 days |
|
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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