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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000905-31 | EudraCT Number |
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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 6-week acute treatment in study NCT00839423 / 11492A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine (Lu AA21004) | Drug | 5 or 10 mg/day; tablets; orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events (AEs) | Up to 52 weeks and a 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 6-week short-term treatment study for Major Depressive Episode (MDE), NCT00839423 / 11492A, followed by a 2-week taper period
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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The study consisted of a 1-week, fixed-dose period with Vortioxetine 10 mg/day, a 51-week flexible dose period with Vortioxetine 5 or 10 mg/day, and a 4-week safety follow up period.
Patients eligible to participate in present study, NCT00761306 / 11492C, were outpatients, who had completed lead-in study NCT00839423 / 11492A immediately prior to inclusion into present study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vortioxetine 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 in Study NCT00761306 / 11492C; MADRS and HAM-D-24: full-analysis set (FAS) = 74 - all patients in the APTS who had at least one valid Baseline and one valid post-Baseline assessment of the MADRS total score in Study NCT00761306 / 11492C.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vortioxetine 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 | Up to 52 weeks and a 4-week safety follow-up period |
|
|
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 5 or 10 mg/Day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thyroiditis | Endocrine disorders | MEDDRA11_0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MEDDRA11_0 | 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 |
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| 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 |
| 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 |
| 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 |
|
|
| 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 | Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score) | FAS; OC | Posted | Number | percentage of patients | Week 52 |
|
|
|
| Secondary | Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) | FAS; OC | Posted | Number | percentage of patients | Week 52 |
|
|
|
| 1 |
| 74 |
| 53 |
| 74 |
| Nausea | Gastrointestinal disorders | MEDDRA11_0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MEDDRA11_0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MEDDRA11_0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MEDDRA11_0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MEDDRA11_0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MEDDRA11_0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA11_0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MEDDRA11_0 | 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.