E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major Depressive Disorder |
Trastorno Depresivo Mayor |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057840 |
E.1.2 | Term | Major depression |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Evaluar la seguridad y tolerabilidad a largo plazo de vortioxetina en niños y adolescentes con diagnóstico de TDM según el DSM-5? |
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E.2.2 | Secondary objectives of the trial |
Evaluation of the long-term effectiveness of flexible doses of vortioxetine in a range of 5 mg/day to 20 mg/day on: - depressive symptoms - clinical global impression - cognitive function - functionality |
Evaluar la efectividad a largo plazo de dosis flexibles de vortioxetina en un intervalo de entre 5 mg/día y 20 mg/día sobre: -los síntomas depresivos; -la impresión clínica global; -la función cognitiva; -la funcionalidad. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The patient is a male or female child aged ? =7 and <12 years or an adolescent aged ? =12 and ?=17 years at Baseline in Study 12712B (patients who turn 18 or 19 years during the study will be allowed to continue in the study). - The patient must have completed extension study 12712A immediately prior to enrolment into this extension study. - The patient had a primary diagnosis of MDD at entry in Study 12709A or 12710A, diagnosed according to DSM-5?. - The patient is still indicated for long-term treatment with vortioxetine according to the clinical opinion of the investigator. |
-Pacientes, niños o niñas, de entre ? =7 y <12 años o adolescentes de entre ?=12 y ?=17 años de edad en la visita basal de la extensión B. -Pacientes que hayan finalizado el estudio de extensión 12712A inmediatamente antes de su inscripción en este estudio de extensión. -Pacientes con un diagnóstico primario de trastorno depresivo mayor (TDM) en el momento de su ingreso al estudio 12709A o 12710A, diagnosticado según el DSM-5?. -Pacientes para los que siga estando indicado el tratamiento a largo plazo con vortioxetina, según la opinión clínica del investigador. |
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E.4 | Principal exclusion criteria |
- The patient has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12712A. - The patient has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication. |
El paciente ha sido diagnosticado con otro desorden psiquiátrico ( por ejemplo manía, trastorno bipolar, esquizofrenia u otro desorden psicótico) durante el estudio 12712A El paciente tiene trastorno de déficit de atención/ hiperactividad ( TDAH) que requiere otro tratamiento farmacológico que medicación estimulante. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety: Safety evaluation based on adverse events, 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. |
eguridad: Evaluación de seguridad basada en los acontecimientos adversos, escala de puntuación de acontecimientos adversos pediátricos (PAERS), pruebas analíticas de seguridad clínica( incluidas las de las hormonas reproductivas) constantes vitales, ciclo menstrual, peso, estatura, Electrocardiogramas (ECG), puntuación de Tanner y (C-SSRS). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the study |
A lo largo del estudio |
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E.5.2 | Secondary end point(s) |
- Change in Children Depression Rating Scale - Revised version (CDRS-R) total score - Number of relapses (CDRS-R ?40 with a history of 2 weeks of clinical deterioration) - Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration) - Change in Clinical Global Impression - Severity of Illness (CGI-S) score - Clinical Global Impression - Global Improvement (CGI-I) score - Children (7-11 years): Change in Behaviour Rating Inventory of Executive Function (BRIEF) using the Global Executive Composite score - Children (7-11 years): Change in BRIEF using the Metacognition Index - Adolescents (12-17 years): Change in Behaviour Rating Inventory of Executive Function - Self-report version (BRIEF-SR) using the Global Executive Composite score - Adolescents (12-17 years): Change in BRIEF-SR using the Metacognition Index - Change in Children?s Global Assessment Scale (CGAS) score - Change in in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scales (PedsQL VAS) score |
-Cambio en la puntuación total de la escala de puntuación de la depresión en niños, versión revisada (CDRS-R). -Número de recidivas (CDRS-R ?40 con antecedentes de 2 semanas de deterioro clínico). -Pérdida de remisión (CDRS-R <28 con antecedentes de 2 semanas de deterioro clínico). -Cambios en la puntuación de la escala de impresión clínica global: gravedad de la enfermedad (CGI-S) -Puntuación de la escala de impresión clínica global: mejoría global (CGI-I) -Niños (7 a 11 años): cambio en el inventario de puntuación conductual de la función ejecutiva (BRIEF), usando la puntuación compuesta global de la función ejecutiva. -Niños (7 a 11 años): cambio en el BRIEF, usando el índice de metacognición. -Adolescentes (12 a 17 años): cambio el inventario de puntuación conductual de la función ejecutiva autoadministrado (BRIEF-SR), usando la puntuación compuesta global de la función ejecutiva. -Adolescentes (12 a 17 años): cambio en el BRIEF-SR, usando el índice de metacognición. -Cambio en la puntuación de la escala de evaluación global del niño (CGAS) -Cambio en la puntuación de la escalas visuales analógicas de funcionamiento actual del PedsQL (EVA del PedsQL) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Throughout the study |
A lo largo del estudio |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 59 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Belgium |
Bulgaria |
Denmark |
Estonia |
Finland |
France |
Germany |
Hungary |
Ireland |
Italy |
Latvia |
Lithuania |
Netherlands |
Poland |
Romania |
Slovakia |
South Africa |
Spain |
Sweden |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
Última visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 21 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 21 |