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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005081-30 | EudraCT Number |
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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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To evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (IV) and vortioxetine 10 mg/day oral dose regimen versus placebo IV and vortioxetine 10 mg/day oral dose regimen on depressive symptoms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV vortioxetine | Experimental |
| |
| IV placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine (IV) | Drug | 17 mg, solution for infusion, administered, over 2 hours as single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 1 in MADRS 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 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 to Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 2 in MADRS 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 to 60. The higher the score, the more severe, 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EE1019 | Tallinn | Estonia | ||||
| EE1020 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31094901 | Derived | Vieta E, Florea I, Schmidt SN, Areberg J, Ettrup A. Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 2-week, randomized, double-blind, placebo-controlled study. Int Clin Psychopharmacol. 2019 Jul;34(4):153-160. doi: 10.1097/YIC.0000000000000271. |
| Label | URL |
|---|---|
| Results EudraCT 2015-005081-30 | View source |
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| Placebo (IV) | Other | Saline: isotonic sodium chloride, administered, over 2 hours as single dose |
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| Vortioxetine (tablet) | Drug | 10 mg, tablets, oral administration once daily for 15 days (open labelled) |
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| Baseline to Week 2 |
| Change from baseline to Day 3 in MADRS 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 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 to Day 3 |
| Change from baseline to Day 1 in MADRS 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 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 to Day 1 |
| Response (defined as a ≥ 50% decrease in MADRS total score from baseline) at Week 1 | Week 1 |
| Remission at Week 1 (defined as a MADRS total score ≤ 10) | Week 1 |
| Change from baseline to Week 1 in HADS depression subscale | The Hospital Anxiety and Depression Scale (HADS) is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21. | baseline to Week 1 |
| Global clinical impression -Global Improvement | The Clinical Global Impression - global improvement CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | At Week 1 |
| Change from baseline in Global clinical impression -Severity | The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients | Baseline to Week 1 |
| Oral clearance (CL/F) | 2, 8 and 24 hours postdose (day 1) and day 14 |
| Average Plasma Concentration (Cav) | 2, 8 and 24 hours postdose (day 1) and day 14 |
| Change from baseline to Week 1 in HADS anxiety subscale | The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21. | Baseline to Week 1 |
| Tallinn |
| Estonia |
| FI1040 | Helsinki | Finland |
| FI1041 | Helsinki | Finland |
| FI1030 | Kuopio | Finland |
| FI1009 | Pori | Finland |
| FI1027 | Turku | Finland |
| 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 |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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