E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major Depressive Disorder |
Disturbo Depressivo Maggiore |
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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. |
valutare la sicurezza e la tollerabilità a lungo termine della vortioxetina in bambini e adolescenti con diagnosi di DDM secondo il 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
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valutare l’efficacia a lungo termine di dosi flessibili di vortioxetina in un intervallo da 5 mg/die a 20 mg/die su:
• sintomi depressivi
• impressione clinica globale
• funzione cognitiva
• funzionalità
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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. |
Il paziente è un bambino o una bambina di età ≥7 e <12 anni o un/un’adolescente di età ≥12 e ≤17 anni alla visita Basale dello studio 12712B (i/le pazienti che compiono 18 o 19 anni durante lo studio potranno proseguire con lo studio).
-Il paziente deve aver terminato lo studio di estensione 12712A subito prima dell’arruolamento in questo studio di estensione.
-Al momento dell’ingresso nello studio 12709A or 12710A, il/la paziente presentava una diagnosi primaria di DDM secondo il DSM-5™.
-Secondo il parere clinico dello sperimentatore, il paziente è ancora idoneo a ricevere il trattamento a lungo termine con vortioxetina.
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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. |
Pazienti a cui sia stato diagnosticato un altro disturbo psichiatrico (per esempio, mania, disturbo bipolare, schizofrenia o altri disturbi psicotici durante lo studio 12712A.
-Pazienti con una sindrome da deficit di attenzione e iperattività (ADHD) che richiede un trattamento farmacologico diverso da un farmaco stimolante.
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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. |
Sicurezza
- Valutazione della sicurezza in base agli eventi avversi, alla scala di valutazione degli eventi avversi pediatrici (Paediatric Adverse Event Rating Scale, PAERS), ai test di laboratorio sulla sicurezza clinica (compresi gli ormoni riproduttivi), ai segni vitali, al peso, all’altezza, al punteggio Tanner, al ciclo mestruale, all’ECG e alla Scala della Columbia University per la valutazione della gravità del rischio di suicidio (Columbia - Suicide Severity Rating Scale, C-SSRS).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the study |
durante il corso dello studio |
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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 |
- Cambiamenti nel punteggio totale della Scala di valutazione della depressione infantile - Versione rivista (Children’s Depression Rating Scale - Revised, CDRS-R)
- Numero di recidive (CDRS-R ≥ 40 con un’anamnesi di deterioramento clinico di 2 settimane)
- Perdita di remissione (CDRS-R < 28 con un’anamnesi di deterioramento clinico di 2 settimane)
- Cambiamenti nel punteggio dell’Impressione clinica globale - Gravità della malattia (Clinical Global Impression - Severity of illness, CGI-S)
- Impressione clinica globale - Miglioramento globale (Clinical Global Impression Scale - Improvement, CGI-I)
- Bambini (7-11 anni): cambiamenti nell’Inventario di valutazione del comportamento della funzione esecutiva (Behaviour Rating Inventory of Executive Function, BRIEF) utilizzando il punteggio Global Executive Composite
- Bambini (7-11 anni): cambiamenti nel BRIEF utilizzando l’indice di metacognizione
- Adolescenti (12-17 anni): cambiamenti nell’Inventario di valutazione del comportamento della funzione esecutiva - Versione per l’autovalutazione (Behaviour Rating Inventory of Executive Function - Self-Report, BRIEF-SR) utilizzando il punteggio composito esecutivo globale (Global Executive Composite)
- Adolescenti (12-17 anni): cambiamenti in BRIEF-SR utilizzando l’Indice di metacognizione
- Cambiamenti nel punteggio della Scala di valutazione globale dei bambini (Children’s Global Assessment Scale, CGAS)
- Cambiamenti nel punteggio delle Scale analogico visive della funzionalità presente dell’Inventario sulla qualità della vita in soggetti pediatrici (Paediatric Quality of Life Visual Analogue Scales, PedsQL VAS)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Throughout the study |
durante il corso dello studio |
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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 | 9 |
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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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 |