Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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To assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning, attention) in working patients with major depressive disorder (MDD).

Official Title
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An Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced (Paroxetine), Fixed-dose Study on the Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Vortioxetine 10 mg
* Drug: Paroxetine 20 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™) recurrent major depressive disorder (MDD) (classification 296.3x). The patient has a MADRS total score ≥26. The patient has had the current major depressive episode (MDE) for ≥3 months. The patient is aged ≥18 and ≤65 years. The patient is employed full or part-time (defined as minimum 50% full time working hours per week). Part time work should not be due to a medical or mental illness other than MDD. The patient has been in the current job/position for at least 3 months. The patient has no plans to change jobs or retire within treatment period. The patient is not on a sick leave, and at the Screening and Randomisation Visits, there are no plans to send the patient on a sick leave. The patient is not receiving disability benefits. Exclusion criteria: The patient has a score ≥70 on the DSST (number of correct symbols) at the Baseline Visit. The patient is, in the opinion of the investigator, not able to complete the neuropsychological tests validly at the Baseline Visit. The patient has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests. The patient is diagnosed with reading disability (dyslexia). The patient has a history of lack of response to previous adequate treatment with vortioxetine or paroxetine. The patient has any current psychiatric disorder or Axis I disorder (according to DSM-IV-TR™ criteria) other than MDD, as assessed using MINI. The patient has a current or has had a diagnosis of dysthymic disorder within 3 months preceding the onset of current episode (DSM-IV-TR™ criteria). The patient has borderline, schizotypal, schizoid, paranoid, or histrionic, antisocial personality disorders (axis II) as comorbid or primary diagnosis (DSM-IV-TR™ criteria). The patient suffers from personality disorders, mental retardation, pervasive development disorder, attention-deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria). The patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (DSM-IV-TR™ criteria). Other protocol-defined inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 10 mg<br>daily, encapsulated, orally | Drug: Vortioxetine 10 mg<br> <br> * Other names: Lu AA21004;|
| Other: Paroxetine 20 mg (active reference)<br>daily, encapsulated, orally | Drug: Paroxetine 20 mg<br> <br> |
| Placebo Comparator: Placebo<br>capsules, orally | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Digit Symbol Substitution Test (DSST): number of correct symbols |  | Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Trail Making Test (TMT) score: TMT-A; speed of processing |  | Baseline to Week 8 | 
| Change in TMT-B; executive functioning |  | Baseline to Week 8 | 
| Change in reaction time score: Choice Reaction Time (CRT); attention |  | Baseline to Week 8 | 
| Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed) |  | Baseline to Week 8 | 
| Change in Stroop Colour Naming Test (STROOP): incongruent score; executive functioning |  | Baseline to Week 8 | 
| Change in STROOP: congruent score; speed of processing |  | Baseline to Week 8 | 
| Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score |  | Baseline to Week 8 | 
| Change in Montgomery and Asberg Depression Rating Scale (MADRS) total score |  | Baseline to Week 8 | 
| Change in Clinical Global Impression - Severity of Illness (CGI-S) |  | Baseline to Week 8 | 
| Clinical Global Impression - Global Improvement (CGI-I) score |  | Week 8 | 
| Change in the Functioning Assessment Short Test (FAST) total score |  | Baseline to Week 8 | 
| Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score |  | Baseline to Week 8 |