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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001515-29 | EudraCT Number |
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The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Vortioxetine (Lu AA21004) 5 mg | Experimental |
| |
| Vortioxetine (Lu AA21004) 10 mg | Experimental |
| |
| Venlafaxine XL 225 mg | Other | Active Reference |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | capsules, daily, orally |
| |
| Vortioxetine (Lu AA21004) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MADRS Total Score After 6 Weeks of Treatment | 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. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MADRS Total Score After 1 Week of Treatment | Baseline and Week 1 | |
| Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment | The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria may apply.
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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 |
|---|---|---|---|
| 21767441 | Result | Alvarez E, Perez V, Dragheim M, Loft H, Artigas F. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012 Jun;15(5):589-600. doi: 10.1017/S1461145711001027. Epub 2011 Jul 18. |
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Eligible patients were randomised equally (1:1:1:1) to one of the 4 treatment arms for a 6-week double-blind treatment period. The doses of Vortioxetine were 5 mg/day or 10 mg/day for 6 weeks. The dose of venlafaxine was 75 mg/day for 4 days, 150 mg/day for the following 3 days, and 225 mg/day for the remainder of the treatment period.
Outpatients with Major Depressive Episode (MDE) were recruited from psychiatric settings.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | capsules, daily, orally |
| FG001 | Vortioxetine 5 mg | encapsulated tablets, daily, orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
encapsulated tablets, daily, orally |
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| Venlafaxine XL | Drug | capsules, daily, orally |
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| Baseline and Week 6 |
| Change From Baseline in HAM-A Total Score After 6 Weeks of 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. | Baseline and Week 6 |
| Change From Baseline in CGI-S Score After 6 Weeks of 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. | Baseline and Week 6 |
| Change in Clinical Status Using CGI-I Score at Week 6 | The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. | Week 6 |
| Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) | Week 6 |
| Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10) | Week 6 |
| FG002 |
| Vortioxetine 10 mg |
encapsulated tablets, daily, orally |
| FG003 | Venlafaxine 225 mg | capsules, daily, orally |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | capsules, daily, orally |
| BG001 | Vortioxetine 5 mg | encapsulated tablets, daily, orally |
| BG002 | Vortioxetine 10 mg | encapsulated tablets, daily, orally |
| BG003 | Venlafaxine 225 mg | capsules, daily, orally |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| MADRS: Baseline Total Score | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Baseline 24-item HAM-D Total Score | The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| HAM-A: Baseline Total Score | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| CGI-S: Baseline Severity Score | 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. | Mean | Standard Deviation | units on a scale |
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| 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 After 6 Weeks of Treatment | 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. | Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid baseline and one valid post-baseline assessment of the MADRS total score; Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
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| Secondary | Change From Baseline in MADRS Total Score After 1 Week of Treatment | FAS, LOCF. Please note that 1 patient in each Vortioxetine group did not have a valid MADRS assessment at Week 1, but were included in the analysis because they had a valid MADRS assessment after Week 1. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Secondary | Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment | The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe. | FAS, LOCF | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
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| Secondary | Change From Baseline in HAM-A Total Score After 6 Weeks of 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. | FAS, LOCF | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
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| Secondary | Change From Baseline in CGI-S Score After 6 Weeks of 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. | FAS, LOCF | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
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| Secondary | Change in Clinical Status Using CGI-I Score at Week 6 | The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. | FAS, LOCF | Posted | Mean | Standard Error | units on a scale | Week 6 |
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| Secondary | Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) | FAS, LOCF | Posted | Number | percentage of patients | Week 6 |
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| Secondary | Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10) | FAS, LOCF | Posted | Number | percentage of patients | Week 6 |
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Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
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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 | Placebo | 0 | 105 | 53 | 105 | |||
| EG001 | Vortioxetine 5 mg | 0 | 108 | 63 | 108 | |||
| EG002 | Vortioxetine 10 mg | 2 | 100 | 66 | 100 | |||
| EG003 | Venlafaxine 225 mg | 1 | 113 | 78 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Varicella | Infections and infestations | MedDRA10_0 | Non-systematic Assessment |
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| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA10_0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA10_0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA10_0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA10_0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA10_0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA10_0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA10_0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA10_0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA10_0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA10_0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA10_0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA10_0 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA10_0 | Non-systematic Assessment |
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| Anorgasmia | Psychiatric disorders | MedDRA10_0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA10_0 | Non-systematic Assessment |
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| Ejaculation delayed | Reproductive system and breast disorders | MedDRA10_0 | Non-systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA10_0 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA10_0 | Non-systematic Assessment |
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The main publication has to be published before any sub publication. The investigators shall obtain Lundbeck's written approval before publishing any publication relating to Vortioxetine, the Study, the Protocol and/or the results recorded during the Study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Lundbeck A/S | H. Lundbeck A/S | +45 3630 1311 | 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 |
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |
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| Male |
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| No |
| Superiority or Other |
| The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate. Null hypothesis: No difference between 5 mg Vortioxetine and placebo at Week 6. | ANCOVA | <0.0001 | The hierarchical hypothesis testing meant that comparison of 5 mg to placebo was performed at a 5% significance level since significance was achieved for the primary comparison of 10 mg to placebo. Since p-value <0.05, hierarchically testing contd. | Mean Difference (Final Values) | -5.90 | Standard Error of the Mean | 1.39 | 2-Sided | 95 | -8.64 | -3.17 | No | Superiority or Other |
| ANCOVA | <0.0001 | This treatment arm was not in the testing sequence. A nominal p-value is provided. | Mean Difference (Final Values) | -6.42 | Standard Error of the Mean | 1.38 | 2-Sided | 95 | -9.13 | -3.72 | No | Superiority or Other |
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