Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes

Study Overview
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Brief Summary
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This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine.

Official Title
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A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Two Doses of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria At least one other MDE before the current one Moderate to severe depression Exclusion Criteria: Any current psychiatric disorder other than Major Depressive Disorder (MDD) as defined in the DSM-IV TR Any substance disorder within the previous 6 months Female patients of childbearing potential who are not using effective contraception Use of any psychoactive medication 2 weeks prior to screening and during the study Randomisation Criteria: Patients in remission (MADRS total score <=10) at both Week 10 and Week 12 Other protocol-defined inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* capsules, daily, orally<br>|
| Experimental: Vortioxetine: 5 or 10 mg<br> | Drug: Vortioxetine (Lu AA21004)<br>* encapsulated tablets, daily, orally<br>* Other names: Brintellix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator | The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe. | Within first 24 weeks of the double-blind period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator |  | Within 64 weeks of the double-blind period | 
| Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment |  | Double-blind Baseline and Week 24 of the double-blind period | 
| Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment | The Hamilton Depression Scale - 17 items (HAM-D-17) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 52. The higher the score, the more severe. | Double-blind Baseline and Week 24 of the double-blind period | 
| Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment | The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe. | Double-blind Baseline and Week 24 of the double-blind period | 
| Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment | The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. | Double-blind Baseline and Week 24 of the double-blind period | 
| Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline) |  | Week 24 of the double-blind period (Counted From Open-label Baseline) | 
| Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10) |  | Week 24 of the double-blind period | 
| Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period | The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe. | Week 24 of the double-blind period (Counted From Double-blind Baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapse prevention, Antidepressants, Placebo-controlled, Double-blind, Multicentre study