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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001871-13 | EudraCT Number |
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This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Vortioxetine: 5 or 10 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | capsules, daily, orally |
| |
| Vortioxetine (Lu AA21004) |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator | 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. | Within first 24 weeks of the double-blind period |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator | Within 64 weeks of the double-blind period | |
| Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment |
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Inclusion Criteria:
Exclusion Criteria:
Randomisation Criteria: Patients in remission (MADRS total score <=10) at both Week 10 and Week 12
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 |
|---|---|---|---|
| 22495621 | Result | Boulenger JP, Loft H, Florea I. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder. J Psychopharmacol. 2012 Nov;26(11):1408-16. doi: 10.1177/0269881112441866. Epub 2012 Apr 9. | |
| 31818787 | Derived | Christensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13. |
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The study consisted of two consecutive periods: a 12-week open-label treatment period with Vortioxetine and a double-blind, fixed-dose, placebo-controlled treatment period of at least 24 weeks.
Patients were in- and outpatients from psychiatric settings.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo : capsules, daily, orally |
| FG001 | Vortioxetine: 5 or 10 mg | Vortioxetine (Lu AA21004) : encapsulated tablets, daily, orally |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Open-label Period |
|
| |||||||||||||||||||||
| Open-label Period to Double-blind Period |
| ||||||||||||||||||||||
| Double-blind Period |
|
The total number of patients under Baseline Measures is not 1035 as automatically calculated, but 639 as stated in the "Open-label Period (APTS)" column and 396 in the "Double-blind Period (FAS)".
The "Total" column of each Baseline Measure is Double-blind Period (FAS).
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-label Period (APTS) | |
| BG001 | Placebo - Double-blind Period (FAS) | Placebo : capsules, daily, orally |
| BG002 |
| 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 | Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator | 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 | Posted | Number | percentage of patients who relapsed | Within first 24 weeks of the double-blind period |
|
Serious Adverse Events: 12-week open-label period, 24-week double-blind period and 4-week safety follow-up period. Other Adverse Events: 12-week open-label period and 24-week double-blind 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 | Open-label Period (APTS) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stress cardiomyopathy | Cardiac disorders | MEDDRA12_0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MEDDRA12_0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Lundbeck A/S | H. Lundbeck A/S | 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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| Drug |
encapsulated tablets, daily, orally |
|
|
| Double-blind Baseline and Week 24 of the double-blind period |
| Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment | The Hamilton Depression Scale - 17 items (HAM-D-17) 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 52. The higher the score, the more severe. | Double-blind Baseline and Week 24 of the double-blind period |
| Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind 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. | Double-blind Baseline and Week 24 of the double-blind period |
| Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind 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. | Double-blind Baseline and Week 24 of the double-blind period |
| Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline) | Week 24 of the double-blind period (Counted From Open-label Baseline) |
| Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10) | Week 24 of the double-blind period |
| Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period | 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. | Week 24 of the double-blind period (Counted From Double-blind Baseline) |
| 27780334 | Derived | McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744. |
| Other Reasons |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| Vortioxetine: 5 or 10 mg - Double-blind Period (FAS) |
Vortioxetine (Lu AA21004) : encapsulated tablets, daily, orally |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | 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-17 | The Hamilton Depression Scale - 17 items (HAM-D-17) 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 52. 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 |
|
| OG001 | Vortioxetine: 5 or 10 mg | encapsulated tablets, daily, orally |
|
|
|
| Secondary | Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator | FAS | Posted | Number | percentage of patients who relapsed | Within 64 weeks of the double-blind period |
|
|
|
|
| Secondary | Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment | FAS; observed cases (OC) | Posted | Mean | Standard Error | units on a scale | Double-blind Baseline and Week 24 of the double-blind period |
|
|
|
|
| Secondary | Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment | The Hamilton Depression Scale - 17 items (HAM-D-17) 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 52. The higher the score, the more severe. | FAS; OC | Posted | Mean | Standard Error | units on a scale | Double-blind Baseline and Week 24 of the double-blind period |
|
|
|
|
| Secondary | Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind 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 Error | units on a scale | Double-blind Baseline and Week 24 of the double-blind period |
|
|
|
|
| Secondary | Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind 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 Error | units on a scale | Double-blind Baseline and Week 24 of the double-blind period |
|
|
|
|
| Secondary | Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline) | FAS; OC | Posted | Number | percentage of patients | Week 24 of the double-blind period (Counted From Open-label Baseline) |
|
|
|
|
| Secondary | Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10) | FAS; OC | Posted | Number | percentage of patients | Week 24 of the double-blind period |
|
|
|
|
| Secondary | Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period | 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 Error | units on a scale | Week 24 of the double-blind period (Counted From Double-blind Baseline) |
|
|
|
|
| 14 |
| 639 |
| 337 |
| 639 |
| EG001 | Placebo - Double-blind Period (FAS) | 6 | 192 | 73 | 192 |
| EG002 | Vortioxetine: 5 or 10 mg - Double-blind Period (FAS) | 7 | 204 | 79 | 204 |
| Abdominal pain | Gastrointestinal disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MEDDRA12_0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MEDDRA12_0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MEDDRA12_0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MEDDRA12_0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MEDDRA12_0 | Non-systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MEDDRA12_0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MEDDRA12_0 | Non-systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MEDDRA12_0 | Non-systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MEDDRA12_0 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MEDDRA12_0 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA12_0 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MEDDRA12_0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA12_0 | Non-systematic Assessment |
|
| Sebaceous carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA12_0 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Serotonin syndrome | Nervous system disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Abortion incomplete | Pregnancy, puerperium and perinatal conditions | MEDDRA12_0 | Non-systematic Assessment |
|
| Alcohol abuse | Psychiatric disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Social stay hospitalisation | Social circumstances | MEDDRA12_0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MEDDRA12_0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MEDDRA12_0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MEDDRA12_0 | Non-systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MEDDRA12_0 | Non-systematic Assessment | Everything beyond the prescribed dose, for instance one extra tablet, is counted as an overdose. |
|
| Dizziness | Nervous system disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA12_0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MEDDRA12_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.