Exploratory Study of the Effects of Vortioxetine (Lu AA21004) on Cognition and Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Subjects Remitted From Depression and in Controls

Study Overview
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Brief Summary
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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.

Official Title
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Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Exploratory Study Investigating the Effects of [Vortioxetine] Lu AA21004 on Cognition and BOLD fMRI Signals in Subjects Remitted From Depression and Controls

Conditions
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Depression

Intervention / Treatment
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* Drug: Vortioxetine (Lu AA21004)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects must have: a Hamilton Depression Rating Scale (HAM-D17) total score ≤ 7 Subjects remitted from depression must: be in remission from recurrent depression having suffered from at least two previous Major Depressive Episodes (MDEs) have received prescribed treatment with an antidepressant or a recognised psychotherapy for depression for a previous MDE report present subjective cognitive dysfunction not have been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to screening visit Control group subjects must: have no history of MDEs have no history of MDEs in a biological parent or other first degree relative as reported by the subject not report present subjective cognitive dysfunction never have been treated with antidepressants or psychotherapy Exclusion Criteria: The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vortioxetine<br> | Drug: Vortioxetine (Lu AA21004)<br>* encapsulated 20 mg tablets, orally, once daily for 13 to 14 days<br>* Other names: Brintellix;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* capsules, orally, once daily for 13 to 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |