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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2007-004992-21 | Registry Identifier | EudraCT |
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The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 8-week acute treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine (Lu AA21004) | Drug | 2.5, 5, or 10 mg/day; tablets; orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events (AEs) | Baseline to end of the 4-week safety follow-up period | |
| Percentage of Patients Who Withdrew Due to Intolerance to Treatment | Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MADRS Total Score After 52 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. |
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Inclusion Criteria:
- Patients who completed 8-week short-term treatment study for Major Depressive Episode, NCT00635219 / 11984A
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 |
|---|---|---|---|
| 22978748 | Result | Baldwin DS, Hansen T, Florea I. Vortioxetine (Lu AA21004) in the long-term open-label treatment of major depressive disorder. Curr Med Res Opin. 2012 Oct;28(10):1717-24. doi: 10.1185/03007995.2012.725035. Epub 2012 Sep 17. |
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The study consisted of a 52-week open-label period and a 4-week Safety Follow-up Period.
Patients eligible to participate in Study 11984B were patients who had completed lead-in Study NCT00635219 / 11984A immediately prior to inclusion into Study 11984B.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vortioxetine 2.5, 5, or 10 mg/Day | tablets; orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Age and Sex: all-patients-treated set (APTS) - all patients who took at least one dose of Vortioxetine after Baseline; MADRS, HAM-D-24, HAM-A, CGI-S and SDS: full-analysis set (FAS) - all patients in the APTS who had at least one valid post-Baseline assessment of the MADRS total score.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vortioxetine 2.5, 5, or 10 mg/Day | tablets; orally |
| 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 | Number of Patients With Adverse Events (AEs) | APTS | Posted | Number | participants | Baseline to end of the 4-week safety follow-up period |
|
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Serious Adverse Events: 52-week open label period and 4-week safety follow-up period Other Adverse Events: 52-week open label 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 | Vortioxetine 2.5, 5, or 10 mg/Day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | 12.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 12.1 | Non-systematic Assessment |
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| 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 |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Baseline and Week 52 |
| Change From Baseline in HAM-D-24 Total Score After 52 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 52 |
| Change From Baseline in HAM-A Total Score After 52 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 52 |
| Change From Baseline in CGI-S Score After 52 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 52 |
| Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score) | Week 52 |
| Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) | Week 52 |
| Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment | Baseline and Week 52 |
| Change From Baseline in SDS Total Score After 52 Weeks of Treatment | 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. | Baseline and Week 52 |
| Protocol Violation |
|
| Withdrawal of Consent |
|
| Lost to Follow-up |
|
| Administrative or Other Reasons |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| MADRS | 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 |
|
| 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 |
|
| 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 |
|
| SDS | 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. | Mean | Standard Deviation | units on a scale |
|
|
| Primary | Percentage of Patients Who Withdrew Due to Intolerance to Treatment | APTS | Posted | Number | percentage of patients | Baseline to Week 52 |
|
|
|
| Secondary | Change From Baseline in MADRS Total Score After 52 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. | FAS; observed cases (OC) | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 52 |
|
|
|
| Secondary | Change From Baseline in HAM-D-24 Total Score After 52 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. | FAS; OC | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 52 |
|
|
|
| Secondary | Change From Baseline in HAM-A Total Score After 52 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; OC | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 52 |
|
|
|
| Secondary | Change From Baseline in CGI-S Score After 52 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; OC | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 52 |
|
|
|
| Secondary | Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score) | FAS; OC; Baseline from lead-in study NCT00635219 / 11984A | Posted | Mean | Standard Deviation | percentage of patients | Week 52 |
|
|
|
| Secondary | Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) | FAS; OC; Baseline from lead-in study NCT00635219 / 11984A | Posted | Mean | Standard Deviation | percentage of patients | Week 52 |
|
|
|
| Secondary | Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment | FAS; OC | Posted | Number | percentage of patients | Baseline and Week 52 |
|
|
|
| Secondary | Change From Baseline in SDS Total Score After 52 Weeks of Treatment | 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. | FAS; OC | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 52 |
|
|
|
| 18 |
| 535 |
| 256 |
| 535 |
| Appendicitis | Infections and infestations | 12.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | 12.1 | Non-systematic Assessment |
|
| Intentional overdose | Injury, poisoning and procedural complications | 12.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | 12.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 12.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | 12.1 | Non-systematic Assessment |
|
| Benign salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 12.1 | Non-systematic Assessment |
|
| Adjustment disorder with mixed anxiety and depressed mood | Psychiatric disorders | 12.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | 12.1 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | 12.1 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | 12.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | 12.1 | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | 12.1 | Non-systematic Assessment |
|
| Dermatitis herpetiformis | Skin and subcutaneous tissue disorders | 12.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | 12.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | 12.1 | Non-systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | 12.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | 12.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | 12.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | 12.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | 12.1 | Non-systematic Assessment |
|
The main publication has to be published before any sub-publications. H. Lundbeck A/S follows the Vancouver declaration with respect to authorship.