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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine (Lu AA21004) | Experimental |
| |
| Venlafaxine extended release | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine (Lu AA21004) | Drug | 10 mg/day |
|
| 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 |
| 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. |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31990207 | Derived | Wang G, Zhao K, Reynaud-Mougin C, Loft H, Ren H, Eriksen HF, Ettrup A. Successfully treated patients with vortioxetine versus venlafaxine: a simplified cost-effectiveness analysis based on a head-to-head study in Asian patients with major depressive disorder. Curr Med Res Opin. 2020 May;36(5):875-882. doi: 10.1080/03007995.2020.1723072. Epub 2020 Feb 13. | |
| 25650503 |
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A Screening Visit was held approximately 7 days prior to group assignment (group assignment was held during the Baseline Visit). Patients who met each of the inclusion criteria at the Screening and Baseline Visits and none of the exclusion criteria at the Screening and/or Baseline Visit were eligible to participate in this study.
In- or outpatients with a primary diagnosis of recurrent of Major Depressive Disorder (MDD) were recruited for this study from China, South Korea, Taiwan, and Thailand.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vortioxetine | Vortioxetine (Lu AA21004): 10 mg/day |
| FG001 | Venlafaxine | Venlafaxine extended release 150 mg/day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The all-patients-treated set (APTS) comprises all randomized patients who took at least one dose of IMP.
Baseline age and gender is based on the APTS. Baseline efficacy outcome measures is based on the full-analysis set (FAS).
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| ID | Title | Description |
|---|---|---|
| BG000 | Vortioxetine | Vortioxetine (Lu AA21004): 10 mg/day |
| BG001 | Venlafaxine | Venlafaxine extended release: 150 mg/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score. | Mean | Standard Error | units on a scale | Baseline and Week 8 |
|
Baseline to 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vortioxetine | Vortioxetine (Lu AA21004): 10 mg/day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 16.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Email contact via H. Lundbeck A/S | Study Director | LundbeckClinicalTrials@lundbeck.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Venlafaxine extended release | Drug | 150 mg/day |
|
|
| 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 |
| Wang G, Gislum M, Filippov G, Montgomery S. Comparison of vortioxetine versus venlafaxine XR in adults in Asia with major depressive disorder: a randomized, double-blind study. Curr Med Res Opin. 2015 Apr;31(4):785-94. doi: 10.1185/03007995.2015.1014028. Epub 2015 Feb 19. |
| Non-compliance |
|
| Protocol Violation |
|
| Withdrawal of consent |
|
| Lost to Follow-up |
|
| Administrative or other reason(s) |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| MADRS total score | 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. | Mean | Standard Deviation | units on a scale |
|
| HAM-A total score | 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. Total score from 0 to 56; higher score indicates greater anxiety. | Mean | Standard Deviation | units on a scale |
|
| CGI-S score | 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 patient is more ill. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Venlafaxine | Venlafaxine extended release: 150 mg/day |
|
|
|
| Secondary | 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. | The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score. | Mean | Standard Error | units on a scale | Baseline and Week 8 |
|
|
|
|
| Secondary | 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. | The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score. | Mean | Standard Error | units on a scale | Week 8 |
|
|
|
|
| Secondary | 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. | The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score. | Mean | Standard Error | units on a scale | Baseline and Week 8 |
|
|
|
|
| Secondary | MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline) | The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score. | Number | percentage of patients | Week 8 |
|
|
|
|
| Secondary | Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10) | The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score. | Number | percentage of patients | Week 8 |
|
|
|
|
| Secondary | Number of Adverse Events | Baseline to Week 12 |
| 2 |
| 211 |
| 90 |
| 211 |
| EG001 | Venlafaxine | Venlafaxine extended release: 150 mg/day | 8 | 226 | 124 | 226 |
| Asthenia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Varicocele | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
|
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