Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries

Study Overview
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Brief Summary
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This study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).

Official Title
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Randomised, Double-blind, Parallel-group, Active-comparator (Venlafaxine Extended Release), Fixed-dose Study of [Vortioxetine] Lu AA21004 in Major Depressive Disorder in Asian Countries

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Vortioxetine (Lu AA21004)
* Drug: Venlafaxine extended release


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient suffers from recurrent MDD as the primary diagnosis according to DSM-IVTR™ criteria. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI) The patient has a MADRS total score ≥26 The patient has a CGI-S score ≥4 The reported duration of the current MDE is ≥3 months. Other inclusion criteria may apply. Exclusion Criteria: - The patient meets any of the exclusion criteria listed in the protocol or, in the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any reason.

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 (Lu AA21004)<br> | Drug: Vortioxetine (Lu AA21004)<br>* 10 mg/day<br>* Other names: Brintellix;|
| Active Comparator: Venlafaxine extended release<br> | Drug: Venlafaxine extended release<br>* 150 mg/day<br>* Other names: Efexor® XL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in MADRS Total Score at Week 8 | Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. | Baseline and Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CGI-S Score From Baseline to Week 8 | Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. | Baseline and Week 8 | 
| CGI-I Score at Week 8 | The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. Higher score = more affected. | Week 8 | 
| Change in HAM-A Total Score From Baseline to Week 8 | Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56. Higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. | Baseline and Week 8 | 
| MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline) |  | Week 8 | 
| Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10) |  | Week 8 | 
| Number of Adverse Events |  | Baseline to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDD