E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Depressive symptoms in patients with major depressive disorder (MDD) and early dementia |
Sintomi depressivi in pazienti con disturbo depressivo maggiore (MDD) e demenza precoce |
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E.1.1.1 | Medical condition in easily understood language |
Depression and dementia |
Depressione e demenza |
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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 | 21.1 |
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 |
To assess the effectiveness of 12-week acute treatment with flexible dose 5-20 mg/day vortioxetine on depressive symptoms in patients with major depressive disorder (MDD) and early dementia |
Valutare l'efficacia di un trattamento acuto di 12 settimane con vortioxetina a una dose flessibile di 5-20 mg/die su sintomi depressivi in pazienti con disturbo depressivo maggiore (MDD) e demenza precoce |
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E.2.2 | Secondary objectives of the trial |
To assess the effectiveness of 12-week acute treatment with 5-20 mg/day vortioxetine on: • cognitive function • functioning • global clinical impression • depression • health-related quality of life |
Valutare l'efficacia di un trattamento acuto di 12 settimane con vortioxetina a una dose di 5-20 mg/die su: • funzione cognitiva • funzionalità • impressione clinica globale • depressione • qualità della vita correlata alla salute |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• The patient has a primary diagnosis of recurrent Major Depressive Disorder (MDD) with onset before age of 55, diagnosed according to DSM-5® • The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (MINI). • The patient has had the current MDE for <6 months. • The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score =26 at the Baseline Visit. • The diagnosis of onset of dementia has occurred at least 6 months prior to screening and after already being diagnosed with MDD. The diagnosis of dementia must be documented in patient's medical records. When deemed necessary per investigator judgement of patient clinical status and early dementia, the patient must be accompanied by a caregiver to study visits. • Patients with dementia associated with vitamin B12 or folate deficiency should not be enrolled. • Patients with or without treatment for dementia can be enrolled. For patients on treatment for dementia, there must be no change in treatment during the study and patients must be on stable dose for at least 3 months prior to the Screening Visit. • The patient has Mini Mental State Examination (MMSE) total score 2024, inclusive. |
• Il paziente ha una diagnosi primaria di disturbo depressivo maggiore (MDD) ricorrente, con comparsa prima dei 55 anni di età, diagnosticato secondo i criteri del DSM-5® • L’attuale episodio depressivo maggiore (MDE) deve essere confermato mediante l’intervista Mini International Neuropsychiatric Interview (MINI). • Il paziente presenta l’attuale MDE da <6 mesi. • Il paziente ha un punteggio totale al basale = 26 della Montgomery and Åsberg Depression Rating Scale (MADRS). • La diagnosi di comparsa di demenza è stata fatta almeno 6 mesi prima dello screening e successivamente alla diagnosi di MDD. La diagnosi di demenza deve essere documentata nella cartella clinica del paziente. Qualora ritenuto necessario dallo sperimentatore in base alla valutazione dello stato clinico e della demenza precoce del paziente, questi dovrà essere accompagnato alle visite dello studio da un caregiver. • I pazienti con demenza associata a carenza di vitamina B12 o folato non devono essere arruolati. • I pazienti trattati o non trattati per demenza possono essere arruolati. Ai pazienti trattati per demenza non deve essere modificato il trattamento per la stessa nel corso dello studio, e devono aver assunto una dose stabile del loro trattamento per almeno 3 mesi prima della Visita di screening. • Il paziente ha un punteggio totale della Mini Mental State Examination (MMSE) tra 20 e 24 inclusi. |
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E.4 | Principal exclusion criteria |
The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview. |
Alla diagnosi primaria, oltre a MDD, il paziente presenta una qualsiasi patologia psichiatrica corrente o disturbo di Asse I (criteri del DSM-5®), in base alla valutazione effettuata mediante l’intervista Mini International Neuropsychiatric Interview (MINI) o altra intervista diagnostica. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score |
Variazione del punteggio totale della Montgomery and Åsberg Depression Rating Scale (MADRS) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to Week 12 |
Dal baseline alla settimana 12 |
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E.5.2 | Secondary end point(s) |
• Change in Digit-Symbol Substitution Test (DSST) Substitution Test (DSST) score* • Change in Rey Auditory Verbal Learning Test (RAVLT) score* • Change in Instrumental Activities of Daily Living (IADL) score* • Change in Clinical Global Impression - Severity (CGI-S) score* • Clinical Global Impression - Improvement (CGI-I) score** • Response (defined as a 50% decrease from baseline in MADRS total score)** • Remission (MADRS =10)** • Change in Bath Assessment of Subjective Quality of Life in Dementia (BASQID) score* |
• Variazione del punteggio della Digit-Symbol Substitution Test (DSST)* • Variazione del punteggio della Rey Auditory Verbal Learning Test (RAVLT)* • Variazione del punteggio della Instrumental Activities of Daily Living (IADL)* • Variazione del punteggio della scala Clinical Global Impression - Severity (CGI-S)* • Punteggio della scala Clinical Global Impression - Improvement (CGI-I)** • Risposta (definita come 50% di riduzione del punteggio totale basale della MADRS)** • Remissione (MADRS =10)** • Variazione del punteggio della Bath Assessment of Subjective Quality of Life in Dementia (BASQID)* |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
* From baseline to Week 12 ** At Week 12 |
* Dal baseline alla settimana 12 ** Settimana 12 |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 | Information not present in EudraCT |
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 |
Estonia |
Finland |
France |
Italy |
Korea, Republic of |
Spain |
Switzerland |
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E.8.7 | Trial has a data monitoring committee | No |
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
|
The overall end of the study is defined as the last protocol-specified contact with the last patient ongoing in the study. The last protocolspecified contact is a safety follow-up. This may be a telephone contact, unless an SAE has occurred since the previous visit. The safety follow-up must be conducted 4 weeks after the last dose of IMP. |
La fine della sperimentazione è definita dall’ultimo contatto specificato da protocollo con l’ultimo paziente in studio. L’ultimo contatto specificato da protocollo è il follow-up di sicurezza. Questo si può svolgere telefonicamente, salvo qualora sia comparso un SAE dalla precedente visita. Il follow-up di sicurezza deve essere eseguito 4 settimane dopo l’ultima dose di IMP. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |