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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002658-11 | EudraCT Number |
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Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine | Experimental | Once daily dosing of vortioxetine (oral tablets) for 78 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine | Drug | Target dose is 10 mg/day; the dose can be down- or uptitrated to 5, 15, or 20 mg/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (Safety) | Based on safety assessments (e.g. paediatric adverse event rating scale (PAERS), clinical safety laboratory tests (including reproductive hormones), vital signs, weight, height, Tanner score, menstrual cycle, ECG, and C-SSRS | Up to Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CDRS-R total score | Children Depression Rating Scale, revised version | Change from study 12712A baseline to Week 104 |
| Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration) |
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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 |
|---|---|---|---|---|---|---|
| MHAT "Targovishte" AD | Targovishte | Bulgaria | ||||
| DCC Mladost-M |
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Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)
| Up to Week 104 |
| Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration) | Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration) | Up to Week 104 |
| Change in CGI-S score | Clinical Global Impression - Severity of Illness | Change from study 12712A baseline to Week 104 |
| CGI-I score | Clinical Global Impression - Global Improvement | Week 104 |
| Children (7-11 years): change in BRIEF using the Global Executive Composite score | Behaviour Rating Inventory of Executive Function | Change from study 12712A baseline to Week 104 |
| Children (7-11 years): change in BRIEF using the Megacognition Index | Behaviour Rating Inventory of Executive Function | Change from study 12712A baseline to Week 104 |
| Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score | Behaviour Rating Inventory of Executive Function, Self-report version | Change from study 12712A baseline to Week 104 |
| Adolescents (12-17 years): change in BRIEF-SR using the Megacognition Index | Behaviour Rating Inventory of Executive Function, Self-report version | Change from study 12712A baseline to Week 104 |
| Change in CGAS score | Children's Global Assessment Scale | Change from study 12712A baseline to Week 104 |
| Change in PedsQL VAS score | Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales | Change from study 12712A baseline to Week 104 |
| Varna |
| Bulgaria |
| Marienthal Center of Psychiatry and Psychology | Tallinn | Estonia |
| CHU de Nantes - Hopital Hotel Dieu | Nantes | France |
| Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri | Mainz | Germany |
| Vadaskert Alapitvany | Budapest | Hungary |
| Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza | Gyula | Hungary |
| Scientific Institute Fondazione Stella Maris | Calambrone | Italy |
| Universita degli Studi di Messina - Facolta di Medicina e Chirurgia | Messina | Italy |
| Linda Keruze's Psychiatric Center, LLC | Liepāja | Latvia |
| Prywatne Gabinety Lekarskie ¿Promedicus¿ Anna Agnieszka Tomczak | Bialystok | Poland |
| Centrum Badan Klinicznych PI-House Sp. z o.o. | Gdansk | Poland |
| Przychodnia Syntonia Poradnia Zdrowia Psychicznego | Kielce | Poland |
| SPECTRUM Centrum Neurologii i Psychiatrii | Lublin | Poland |
| Filip Rybakowski Specjalistyczna Praktyka Lekarska | Poznan | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej (SPZOZ) - Centrum Neuropsychiatrii "NEUROMED" | Wroclaw | Poland |
| Specialized Clinical Psychiatric Hospital 1 of the Ministry of Health | Krasnodar | Russia |
| Lipetsk Regional Psychoneurological Hospital | Lipetsk | Russia |
| Nizhny Novgorod Region State Institution Of Healthcare | Nizhny Novgorod | Russia |
| Medicorehabilitation Research Center "Phoenix" | Rostov-on-Don | Russia |
| Rostov State Medical University of the Minzdravsotsrazvitiya of Russia | Rostov-on-Don | Russia |
| Guz "Saratov Regional Psychiatric Hospital St. Sofii" | Saratov | Russia |
| Saratov State Medical University | Saratov | Russia |
| State Budgetary Healthcare Institution | Tonnel'nyy | Russia |
| State Budgetary Healthcare Institution of Sverdlovsk Region | Yekaterinburg | Russia |
| Clinic of Neurology and Psychiatry for Children and Adolescents | Belgrade | Serbia |
| Clinical Center of Vojvodina - Clinic of Psychiatry | Novi Sad | Serbia |
| Cape Trial Centre | Bellville | South Africa |
| Hospital General Universitario Gregorio Maranon | Madrid | Spain |
| Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo | Torremolinos | Spain |
| Alder Hey Childrens Hospital | Liverpool | United Kingdom |
| 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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