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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002362-21 | EudraCT Number |
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The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine 10 mg or 20 mg | Experimental |
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| Agomelatine 25 mg or 50 mg | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine (Lu AA21004) | Drug | encapsulated tablets, daily, orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MADRS Total Score at Week 8 | 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, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MADRS Total Score at Week 12 | Baseline and Week 12 | |
| Change From Baseline in HAM-A Total Score at Week 8 | 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; higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. |
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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 |
|---|---|---|---|
| 36708956 | Derived | Adair M, Christensen MC, Florea I, Loft H, Fagiolini A. Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability. J Affect Disord. 2023 May 1;328:345-354. doi: 10.1016/j.jad.2023.01.074. Epub 2023 Jan 26. | |
| 29554497 | Derived |
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The study will consist of a screening period of 4 to 10 days before the Baseline Visit, followed by a 12-week treatment period with vortioxetine or agomelatine. A safety follow-up will be done approximately 4 weeks after the Completion/Withdrawal Visit.
In- or outpatients who had been treated with antidepressant selective serotonin reuptake inhibitor (SSRI) or selective noradrenaline reuptake inhibitor (SNRI) monotherapy that was prescribed to treat a single episode of Major Depressive Disorder (MDD) or recurrent MDD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vortioxetine 10 mg or 20 mg | encapsulated tablets, daily, orally |
| FG001 | Agomelatine 25 mg or 50 mg | encapsulated tablets, daily, orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Agomelatine | Drug | encapsulated tablets, daily, orally |
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| Baseline and Week 8 |
| Change From Baseline in HAM-A Total Score at Week 12 | Baseline and Week 12 |
| Change From Baseline in CGI-S Score at Week 8 | 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. Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. | Baseline and Week 8 |
| Change From Baseline in CGI-S Score at Week 12 | Baseline and Week 12 |
| 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. Higher score = more affected. | Week 8 |
| Change in Clinical Status Using CGI-I Score at Week 12 | Week 12 |
| Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) | Baseline and Week 8 |
| Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) | Baseline and Week 12 |
| Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10) | Week 8 |
| Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10) | Week 12 |
| Change From Baseline in SDS Total Score at Week 8 | 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, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. | Baseline and Week 8 |
| Change From Baseline in SDS Total Score at Week 12 | Baseline and Week 12 |
| Papakostas GI, Nielsen RZ, Dragheim M, Tonnoir B. Efficacy and tolerability of vortioxetine versus agomelatine, categorized by previous treatment, in patients with major depressive disorder switched after an inadequate response. J Psychiatr Res. 2018 Jun;101:72-79. doi: 10.1016/j.jpsychires.2018.02.017. Epub 2018 Feb 22. |
| 25087600 | Derived | Montgomery SA, Nielsen RZ, Poulsen LH, Haggstrom L. A randomised, double-blind study in adults with major depressive disorder with an inadequate response to a single course of selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor treatment switched to vortioxetine or agomelatine. Hum Psychopharmacol. 2014 Sep;29(5):470-82. doi: 10.1002/hup.2424. |
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| NOT COMPLETED |
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Age and Gender: All-patients-treated set (APTS) - all patients in the APRS who took at least one dose of investigational medicinal product (IMP).
Study Specific Characteristics: Full-analysis set (FAS) - all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vortioxetine 10 mg or 20 mg | encapsulated tablets, daily, orally |
| BG001 | Agomelatine 25 mg or 50 mg | encapsulated tablets, daily, orally |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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 - 60. 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; higher score indicates greater anxiety. | Mean | Standard Deviation | units on a scale |
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| 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. Higher score indicates that the patient is more ill. | Mean | Standard Deviation | units on a scale |
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| SDS Total Baseline Score | 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 |
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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 at Week 8 | 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, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. | full-analysis set (FAS) | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
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| Secondary | Change From Baseline in MADRS Total Score at Week 12 | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in HAM-A Total Score at Week 8 | 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; higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. | FAS | 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 at Week 12 | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in CGI-S Score at Week 8 | 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. Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
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| Secondary | Change From Baseline in CGI-S Score at Week 12 | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
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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. Higher score = more affected. | FAS | Posted | Mean | Standard Error | units on a scale | Week 8 |
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| Secondary | Change in Clinical Status Using CGI-I Score at Week 12 | FAS | Posted | Mean | Standard Error | units on a scale | Week 12 |
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| Secondary | Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) | FAS, last observation carried forward (LOCF) | Posted | Number | percentage of participants | Baseline and Week 8 |
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| Secondary | Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) | FAS, LOCF | Posted | Number | percentage of participants | Baseline and Week 12 |
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| Secondary | Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10) | FAS, LOCF | Posted | Number | percentage of participants | Week 8 |
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| Secondary | Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10) | FAS, LOCF | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Change From Baseline in SDS Total Score at Week 8 | 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, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 8 |
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| Secondary | Change From Baseline in SDS Total Score at Week 12 | FAS | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
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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 | 3 | 253 | 82 | 253 | |||
| EG001 | Agomelatine | 4 | 242 | 77 | 242 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peptic ulcer perforation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Social stay hospitalisation | Social circumstances | MedDRA 15.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
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The results of this study will be published. Authors of the primary publication based on this study must fulfil the criteria defined by the International Committee of Medical Journal Editors (ICMJE). The primary publication must be published before any secondary publications are submitted for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Lundbeck A/S | H. Lundbeck A/S | +45 36301311 | 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 |
| C084711 | agomelatine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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