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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020170-42 | EudraCT Number |
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The objective of the study is to evaluate the pharmacokinetics of vortioxetine and its metabolites in connection with multiple oral dosing in child and adolescent patients with a DSM-IV-TR diagnosis of Depressive or Anxiety Disorder
The study will be conducted in the US and in Europe and will include paediatric patients diagnosed with depressive or anxiety disorders of two age populations; children aged 7-11 years and adolescents of the age 12-17 years. It is an open study to allow pharmacokinetic (PK) sampling of all patients and four dose levels will be tested. Following lower initial doses for 2 to 6 days, the patients will be treated once daily at the assigned dose levels for 14 days, and it is expected that patients may benefit from treatment during this period. As the treatment duration is not sufficient according to treatment guidelines, if judged or indicated by the investigator, the patients are offered to continue in an extension treatment of up to six months to allow possibility for therapeutic satisfaction.
Preferably, the cohorts will be dosed in the following order: AC1, AC2, CC1, AC3, CC2, AC4, CC3, and CC4. An external data safety monitoring board (DSMB) will be established to evaluate safety, tolerability and preliminary PK data from the dosed cohort(s) prior to any dosing of subsequent cohort (s). The dose regimen may be adjusted based on the recommendation of the DSMB. Adolescents will be exposed to a certain dose of vortioxetine before children receive the same dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort CC1, 6 children | Experimental |
| |
| Cohort CC2, 6 children | Experimental |
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| Cohort CC3, 6 children | Experimental |
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| Cohort CC4, 6 children | Experimental |
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| Cohort AC1, 6 adolescents | Experimental |
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| Cohort AC2, 6 adolescents | Experimental |
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| Cohort AC3, 6 adolescents | Experimental |
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| Cohort AC4, 6 adolescents |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine | Drug | 5 mg tablets for 14 days; orally; once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Vortioxetine | Maximum plasma concentration of vortioxetine | Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level |
| AUC(0-24h) of Vortioxetine | Area under the vortioxetine plasma concentration-time curve from 0 to 24 hours | Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level |
| t½ of Vortioxetine | Half-life of vortioxetine in plasma | Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level |
| Cmax of Lu AA34443 | Maximum plasma concentration of the major, inactive metabolite Lu AA34443 | Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level |
| AUC(0-24h) of Lu AA34443 | Area under the plasma concentration-time curve from 0 to 24 hours for the major, inactive metabolite Lu AA34443 | Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level |
| t½ of Lu AA34443 | Half-life of the major, inactive metabolite Lu AA34443 in plasma | Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level |
| Oral Clearance (CL/F) of Vortioxetine |
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Inclusion Criteria:
Exclusion Criteria:
Other 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 |
|---|---|---|---|---|---|---|
| US003 | Washington D.C. | District of Columbia | 20010 | United States | ||
| US004 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29035574 | Derived | Findling RL, Robb AS, DelBello MP, Huss M, McNamara NK, Sarkis EH, Scheffer RE, Poulsen LH, Chen G, Lemming OM, Auby P. A 6-Month Open-Label Extension Study of Vortioxetine in Pediatric Patients with Depressive or Anxiety Disorders. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):47-54. doi: 10.1089/cap.2017.0047. Epub 2017 Oct 16. |
| Label | URL |
|---|---|
| EMA EudraCT Results: 2010-020170-42 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adolescents, 5 mg | Vortioxetine: 5 mg tablets for 14 days; orally; once daily |
| FG001 | Adolescents, 10 mg | Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vortioxetine | Drug | 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily |
|
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| Vortioxetine | Drug | 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily |
|
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| Vortioxetine | Drug | 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily |
|
|
Oral clearance expressed as a function of bioavailability
| Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level |
| Wichita |
| Kansas |
| 67214 |
| United States |
| US002 | Cincinnatti | Ohio | 45219 | United States |
| US001 | Cleveland | Ohio | 44106 | United States |
| DE002 | Berlin | 10249 | Germany |
| DE001 | Mainz | 55122 | Germany |
| DE003 | Ulm | 89075 | Germany |
| FG002 | Adolescents, 15 mg | Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily |
| FG003 | Adolescents, 20 mg | Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily |
| FG004 | Children, 5 mg | Vortioxetine: 5 mg tablets for 14 days; orally; once daily |
| FG005 | Children, 10 mg | Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily |
| FG006 | Children, 15 mg | Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily |
| FG007 | Children, 20 mg | Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adolescents, 5 mg | Vortioxetine: 5 mg tablets for 14 days; orally; once daily |
| BG001 | Adolescents, 10 mg | Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily |
| BG002 | Adolescents, 15 mg | Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily |
| BG003 | Adolescents, 20 mg | Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily |
| BG004 | Children, 5 mg | Vortioxetine: 5 mg tablets for 14 days; orally; once daily |
| BG005 | Children, 10 mg | Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily |
| BG006 | Children, 15 mg | Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily |
| BG007 | Children, 20 mg | Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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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 | Cmax of Vortioxetine | Maximum plasma concentration of vortioxetine | Pharmacokinetic analysis set = all patients who took at least one dose of IMP and who contributed with both Day 1 pre-dose pharmacokinetic sampling data and sufficient post-dose sampling data for estimation of the pharmacokinetic parameters. | Posted | Median | Standard Deviation | ng/mL | Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | AUC(0-24h) of Vortioxetine | Area under the vortioxetine plasma concentration-time curve from 0 to 24 hours | Pharmacokinetic analysis set | Posted | Median | Standard Deviation | ng*h/mL | Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | t½ of Vortioxetine | Half-life of vortioxetine in plasma | Pharmacokinetic analysis set | Posted | Median | Standard Deviation | h | Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Cmax of Lu AA34443 | Maximum plasma concentration of the major, inactive metabolite Lu AA34443 | Pharmacokinetic analysis set | Posted | Median | Standard Deviation | ng/mL | Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | AUC(0-24h) of Lu AA34443 | Area under the plasma concentration-time curve from 0 to 24 hours for the major, inactive metabolite Lu AA34443 | Pharmacokinetic analysis set | Posted | Median | Standard Deviation | ng*h/mL | Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | t½ of Lu AA34443 | Half-life of the major, inactive metabolite Lu AA34443 in plasma | Pharmacokinetic analysis set | Posted | Median | Standard Deviation | h | Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Oral Clearance (CL/F) of Vortioxetine | Oral clearance expressed as a function of bioavailability | Pharmacokinetic analysis set | Posted | Median | Standard Deviation | L/h | Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level |
|
4 to 5 weeks, depending on the assigned dose
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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 | Adolescents, 5 mg | Vortioxetine: 5 mg tablets for 14 days; orally; once daily | 0 | 6 | 4 | 6 | ||
| EG001 | Adolescents, 10 mg | Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily | 0 | 6 | 4 | 6 | ||
| EG002 | Adolescents, 15 mg | Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily | 0 | 6 | 5 | 6 | ||
| EG003 | Adolescents, 20 mg | Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily | 0 | 6 | 5 | 6 | ||
| EG004 | Children, 5 mg | Vortioxetine: 5 mg tablets for 14 days; orally; once daily | 0 | 6 | 5 | 6 | ||
| EG005 | Children, 10 mg | Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily | 0 | 6 | 5 | 6 | ||
| EG006 | Children, 15 mg | Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily | 0 | 6 | 5 | 6 | ||
| EG007 | Children, 20 mg | Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily | 0 | 6 | 4 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pica | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Frustration | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Hostility | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Initial insomnia | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Lundbeck | H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| 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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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Germany |
|
| OG004 |
| Children, 5 mg |
Vortioxetine: 5 mg tablets for 14 days; orally; once daily |
| OG005 | Children, 10 mg | Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily |
| OG006 | Children, 15 mg | Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily |
| OG007 | Children, 20 mg | Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily |
|
|
Vortioxetine: 5 mg tablets for 14 days; orally; once daily |
| OG005 | Children, 10 mg | Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily |
| OG006 | Children, 15 mg | Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily |
| OG007 | Children, 20 mg | Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily |
|
|
| Children, 5 mg |
Vortioxetine: 5 mg tablets for 14 days; orally; once daily |
| OG005 | Children, 10 mg | Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily |
| OG006 | Children, 15 mg | Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily |
| OG007 | Children, 20 mg | Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily |
|
|
| OG004 |
| Children, 5 mg |
Vortioxetine: 5 mg tablets for 14 days; orally; once daily |
| OG005 | Children, 10 mg | Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily |
| OG006 | Children, 15 mg | Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily |
| OG007 | Children, 20 mg | Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily |
|
|
| Children, 5 mg |
Vortioxetine: 5 mg tablets for 14 days; orally; once daily |
| OG005 | Children, 10 mg | Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily |
| OG006 | Children, 15 mg | Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily |
| OG007 | Children, 20 mg | Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily |
|
|
| Children, 5 mg |
Vortioxetine: 5 mg tablets for 14 days; orally; once daily |
| OG005 | Children, 10 mg | Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily |
| OG006 | Children, 15 mg | Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily |
| OG007 | Children, 20 mg | Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily |
|
|