E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Under threshold depression of the elderly. |
Depressione sottosoglia dell’anziano. |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012378 |
E.1.2 | Term | 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 |
The primary objective of the study is to evaluate the efficacy of choline alfoscerate on subthreshold depression in elderly patients. |
L'obiettivo primario dello studio è valutare l'efficacia della colina alfoscerato sulla depressione sottosoglia nei pazienti anziani. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are: 1. To evaluate whether choline alfoscerate can determine a specific improvement on the cognitive symptoms associated with subthreshold depression. 2. To evaluate whether choline alfoscerate can lead to a specific improvement in apathy associated with subthreshold depression. |
Gli obiettivi secondari dello studio sono: 1. Valutare se la colina alfoscerato può determinare un miglioramento specifico dei sintomi cognitivi associati alla depressione sottosoglia. 2. Valutare se la colina alfoscerato può portare a un miglioramento specifico dell'apatia associata alla depressione sottosoglia. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age = 65 years 2. From 2 to 4 depressive symptoms present for at least two weeks prior to enrollment (Judd et al., 1994) 3. Mini-Mental State Examination (MMSE) score = 24 4. Montreal Cognitive Assessment (MOCA) score < 26 5. Patients able to understand and sign informed consent 6. Informed consent signature |
1. Età = 65 anni 2. Da 2 a 4 sintomi depressivi presenti per almeno due settimane prima dell’arruolamento (Judd et al., 1994) 3. Punteggio Mini Mental State Examination (MMSE) = 24 4. La valutazione cognitiva di Montreal MOCA < 26 5. Pazienti in grado di comprendere e firmare il consenso informato 6. Firma del consenso informato |
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E.4 | Principal exclusion criteria |
1. Any contraindication to treatment or intolerance to choline alfoscerate 2. Diagnosis of Major Depressive Episode or Dysthymia 3. Diagnosis of Schizophrenia or other psychotic disorders, Bipolar Disorder or Dementia 4. Alcohol / drug / substance abuse or dependence 5. Severe organic disease (eg major surgery, metastatic cancer, stroke, severe neurological disorder, myocardial infarction, chronic heart failure) 6. Treatment with antidepressants or psychotherapy within 2 weeks prior to recruitment 7. Any condition which, in the opinion of the investigator, might put the patient at risk by participation in this study 8. Patients involved in other clinical trials |
1. Qualsiasi controindicazione al trattamento o intolleranza alla colina alfoscerato 2. Diagnosi di episodi depressivi maggiori o distimia 3. Diagnosi di schizofrenia o altri disturbi psicotici, disturbo bipolare o demenza 4. Abuso o dipendenza da alcol/droghe/sostanze 5. Grave malattia organica (ad es. chirurgia maggiore, cancro metastatico, ictus, grave disturbo neurologico, infarto del miocardio, insufficienza cardiaca cronica) 6. Trattamento con antidepressivi o psicoterapia entro 2 settimane prima dell’arruolamento 7. Qualsiasi condizione che, a giudizio dello sperimentatore, potrebbe mettere a rischio il paziente con la partecipazione a questo studio 8. Pazienti coinvolti in altri studi clinici |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective will be evaluated through the analysis of the changes at the final visit from the baseline of the following tests: HAMD-17 (Hamilton Depression Rating Scale-17 items). |
L'obiettivo primario sarà valutato attraverso l'analisi dei cambiamenti dal basale alla visita finale dei seguenti test: HAMD-17 (voci Hamilton Depression Rating Scale-17). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• The depression symptoms associated with subthreshold depression will be evaluated through the analysis of the changes at the final visit from baseline of the following tests: GDS-15 (Geriatric Depression Scale-15 items); CGI-s (Clinical Global Impression-severity). • The cognitive symptoms associated with subthreshold depression will be evaluated through the analysis of the changes at the final visit from baseline of the following tests: MOCA (Montreal Cognitive Assessment) scale. • The apathy associated with subthreshold depression will be evaluated through the analysis of the changes at the final visit from the baseline of the AES-I (Apathy Evaluation Scale-Informant) scale. |
• The depression symptoms associated with subthreshold depression will be evaluated through the analysis of the changes at the final visit from baseline of the following tests: GDS-15 (Geriatric Depression Scale-15 items); CGI-s (Clinical Global Impression-severity). • The cognitive symptoms associated with subthreshold depression will be evaluated through the analysis of the changes at the final visit from baseline of the following tests: MOCA (Montreal Cognitive Assessment) scale. • The apathy associated with subthreshold depression will be evaluated through the analysis of the changes at the final visit from the baseline of the AES-I (Apathy Evaluation Scale-Informant) scale. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
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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 | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |