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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002901-38 | EudraCT Number |
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To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Vortioxetine 5 mg | Experimental |
| |
| Duloxetine 60 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 HAM-D-24 Total Score After 8 Weeks of Treatment | The Hamilton Depression Scale - 24 Items (HAM-D-24) 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 76. The higher the score, the more severe. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment | Baseline and Week 6 | |
| Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment | Baseline and Week 4 | |
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Inclusion Criteria:
Clinical Diagnosis of recurrent Major Depressive Episode (MDE) according the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria with:
Exclusion Criteria:
Other 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 |
|---|---|---|---|
| 22572889 | Result | Katona C, Hansen T, Olsen CK. A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder. Int Clin Psychopharmacol. 2012 Jul;27(4):215-23. doi: 10.1097/YIC.0b013e3283542457. |
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The study consisted of a Screening Period; an 8-week Core Treatment Period; a 1-week double-blind down-taper period (Week 9); and a 4-week Safety Follow-up Period after completion/withdrawal (Weeks 8 to 12).
Patients were mainly recruited via psychiatric, psycho-geriatric, and geriatric inpatient or outpatient 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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| Duloxetine | Drug | encapsulated tablets; daily; orally |
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| Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment |
| Baseline and Week 2 |
| Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment | Baseline and Week 1 |
| Change From Baseline in MADRS Total Score After 8 Weeks of Treatment | The Montgomery Ã…sberg 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 8 |
| Change From Baseline in HAM-A Total Score After 8 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 8 |
| Change From Baseline in CGI-S Score After 8 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 8 |
| Change in Clinical Status Using CGI-I Score at Week 8 | 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 8 |
| Change From Baseline in GDS Total Score After 8 Weeks of Treatment | The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity. | Baseline and Week 8 |
| Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score) | Week 8 |
| Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) | Week 8 |
| Risk of Suicidality Using C-SSRS Scores | The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with sub-questions that assess severity. The tool was administered via an interview with the patient. | Up to 8 weeks |
| FG002 |
| Duloxetine 60 mg |
encapsulated tablets; daily; orally |
| COMPLETED |
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| NOT COMPLETED |
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Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | capsules; daily; orally |
| BG001 | Vortioxetine 5 mg | encapsulated tablets; daily; orally |
| BG002 | Duloxetine 60 mg | encapsulated tablets; daily; orally |
| BG003 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| HAM-D-24 | The Hamilton Depression Scale - 24 Items (HAM-D-24) 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 76. The higher the score, the more severe. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| MADRS | The Montgomery Ã…sberg 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 |
| ||||||||||||||
| HAM-A | 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 | 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 |
| ||||||||||||||
| GDS | The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity. | 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 HAM-D-24 Total Score After 8 Weeks of Treatment | The Hamilton Depression Scale - 24 Items (HAM-D-24) 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 76. 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 post-baseline assessment of the primary efficacy variable; last observation carried forward (LOCF); analysis of covariance (ANCOVA) | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
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| Secondary | Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment | FAS; LOCF, ANCOVA | Posted | Mean | Standard Error | units on a scale | Baseline and Week 6 |
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| Secondary | Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment | FAS; LOCF; ANCOVA | Posted | Mean | Standard Error | units on a scale | Baseline and Week 4 |
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| Secondary | Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment | FAS; LOCF; ANCOVA | Posted | Mean | Standard Error | units on a scale | Baseline and Week 2 |
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| Secondary | Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment | FAS; LOCF; ANCOVA | Posted | Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Secondary | Change From Baseline in MADRS Total Score After 8 Weeks of Treatment | The Montgomery Ã…sberg 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. | FAS; LOCF; ANCOVA | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
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| Secondary | Change From Baseline in HAM-A Total Score After 8 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; ANCOVA | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
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| Secondary | Change From Baseline in CGI-S Score After 8 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; ANCOVA | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
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| Secondary | Change in Clinical Status Using CGI-I Score at Week 8 | 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; ANCOVA | Posted | Mean | Standard Error | units on a scale | Week 8 |
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| Secondary | Change From Baseline in GDS Total Score After 8 Weeks of Treatment | The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity. | FAS; observed cases (OC); ANCOVA | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
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| Secondary | Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score) | FAS; LOCF | Posted | Number | percentage of patients | Week 8 |
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| Secondary | Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) | FAS; LOCF | Posted | Number | percentage of patients | Week 8 |
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| Secondary | Risk of Suicidality Using C-SSRS Scores | The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with sub-questions that assess severity. The tool was administered via an interview with the patient. | C-SSRS Data by Columbia Classification Algorithm for Suicide Assessment (C-CASA) Category (APTS) | Posted | Number | participants | Up to 8 weeks |
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Serious Adverse Events: 8-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 8-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 | 4 | 145 | 63 | 145 | |||
| EG001 | Vortioxetine 5 mg | 1 | 156 | 72 | 156 | |||
| EG002 | Duloxetine 60 mg | 1 | 151 | 104 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip fracture | Injury, poisoning and procedural complications | MEDDRA12_1 | Non-systematic Assessment |
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| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA12_1 | Non-systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA12_1 | Non-systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MEDDRA12_1 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MEDDRA12_1 | Non-systematic Assessment |
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| Major depression | Psychiatric disorders | MEDDRA12_1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MEDDRA12_1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MEDDRA12_1 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MEDDRA12_1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA12_1 | Non-systematic Assessment |
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| Fatigue | General disorders | MEDDRA12_1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MEDDRA12_1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MEDDRA12_1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA12_1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MEDDRA12_1 | Non-systematic Assessment |
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| Ejaculation delayed | Reproductive system and breast disorders | MEDDRA12_1 | Non-systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MEDDRA12_1 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MEDDRA12_1 | Non-systematic Assessment |
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The main publication has to be published before any sub-publications. H. Lundbeck A/S follows the Vancouver declaration with respect to authorship.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Lundbeck A/S | H. Lundbeck A/S | +45 3630 1311 | LundbeckClinicalTrials@lundbeck.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Male |
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| ANCOVA | <0.0001 | This treatment arm was not in the testing sequence. A nominal p-value is provided. | Mean Difference (Final Values) | -5.48 | Standard Error of the Mean | 1.03 | 2-Sided | 95 | -7.50 | -3.46 | No | Superiority or Other |
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