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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001444-66 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Catania | OTHER |
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Background. Depression is a highly frequent condition in the elderly, with a huge impact on quality of life, life expectancy, and medical outcomes. SSRIs are commonly prescribed in elderly depressed patients and, although generally safe, they may be associated with tolerability issues. Based on available studies, vortioxetine is likely to have a promising tolerability profile in the elderly, as it does not adversely affect psychomotor or cognitive performance, wakefulness, body weight, and electrocardiogram parameters.
Objectives. Assessing the comparative tolerability, safety and efficacy of vortioxetine compared with the SSRIs as a group (including sertraline, citalopram, escitalopram, paroxetine, fluoxetine, fluvoxamine) in elderly patients affected by major depression. The primary outcome will be the withdrawal rate due to adverse events.
Methods. This is a pragmatic, multicenter, open-label, parallel-group, superiority, randomized trial. Twelve Italian Community Psychiatric Services will consecutively enrol elderly patients suffering from an episode of major depression who get in contact over a period of 12 months. By employing the web-based application RedCap, doctors will be able to randomize patients to vortioxetine or one of the SSRIs, chosen on the basis of clinical judgment, and to collect basic socio-demographic and clinical data. Trained and blinded assessors will administer five validated rating scales: Montgomery-Åsberg Depression Rating Scale (MADRS), Antidepressant Side-Effect Checklist (ASEC), EuroQual 5 Dimensions (EQ-5D), Charlson Age-Comorbidity Index (CACI), and Short Blessed Test (SBT). Patients will be assessed after 1, 3 and 6 months.
Expected results. On the basis of current literature, the investigators hypothesize vortioxetine to be superior to SSRIs as a group in terms of tolerability. As vortioxetine is expected to reduce the withdrawal rates due to adverse events of about 12% compared to SSRIs, and assuming that about 23% of the participants could be lost within 6 months, the investigators aim to enrol 358 patients (179 in each group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vortioxetine | Experimental |
| |
| SSRIs | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine | Drug | Antidepressant classified under the category "other antidepressants" according to the ATC/DDD index [ATC=Anatomical Therapeutic Chemical Classification System; DDD=Defined Daily Dose]. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 5-20 mg/day). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants withdrawing from treatment due to adverse events (tolerability) | Participants withdrawing from allocated treatment due to adverse events on the number of randomized patients. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants withdrawing from treatment due to any cause (acceptability) | Participants withdrawing from allocated treatment due to any cause on the number of randomized patients | 6 months |
| Overall mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria Mater Domini, Università Magna Grecia | Catanzaro | Italy | ||||
| Sapienza Università di Roma, Dipartimento di Neurologia e Psichiatria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32746941 | Result | Ostuzzi G, Gastaldon C, Barbato A, D'Avanzo B, Tettamanti M, Monti I, Aguglia A, Aguglia E, Alessi MC, Amore M, Bartoli F, Biondi M, Bortolaso P, Callegari C, Carra G, Caruso R, Cavallotti S, Crocamo C, D'Agostino A, De Fazio P, Di Natale C, Giusti L, Grassi L, Martinotti G, Nose M, Papola D, Purgato M, Rodolico A, Roncone R, Tarsitani L, Turrini G, Zanini E, Amaddeo F, Ruggeri M, Barbui C. Tolerability and efficacy of vortioxetine versus SSRIs in elderly with major depression. Study protocol of the VESPA study: a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial. Trials. 2020 Aug 3;21(1):695. doi: 10.1186/s13063-020-04460-6. | |
| 40679716 |
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Pragmatic, multicenter, open-label, parallel-group, superiority, randomized trial.
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| Sertraline | Drug | Antidepressant classified under the category "Selective serotonin reuptake inhibitors" according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 50-200 mg/day). |
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| citalopram | Drug | Antidepressant classified under the category "Selective serotonin reuptake inhibitors" according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 10-20 mg/day). |
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| Escitalopram | Drug | Antidepressant classified under the category "Selective serotonin reuptake inhibitors" according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 5-10 mg/day). |
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| Paroxetine | Drug | Antidepressant classified under the category "Selective serotonin reuptake inhibitors" according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 20-40 mg/day). |
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| Fluoxetine | Drug | Antidepressant classified under the category "Selective serotonin reuptake inhibitors" according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 20-60 mg/day). |
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| Fluvoxamine | Drug | Antidepressant classified under the category "Selective serotonin reuptake inhibitors" according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 100-300 mg/day). |
|
The number of deaths on the number of randomized patients
| 6 months |
| Number of participants with at least one episode of self-harm | Number of participants with at least one episode of self-harm on the number of randomized patients | 6 months |
| Number of participants died by suicide | Number of participants died by suicide on the number of randomized patients | 6 months |
| Treatment-related adverse events as assessed by the ASEC | The mean change score at the Antidepressant Side-Effect Checklist (ASEC). ASEC is a validated rating scale, administered by the clinician, measuring the occurrence and severity of 21 adverse events of antidepressants drugs. For each side effect, a score between 0 (absent) to 3 (severe) is reported. Also, the likelihood of its association with antidepressants is assessed with a yes/no question. Single side-effects scores are summed to obtain a total score (ranging from 0 to 63). | 6 months |
| Number of participants with a reduction of at least 50% of the baseline score of the MADRS (responders) | The number of participants with a reduction of at least 50% of the baseline score of the Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS is a validated rating scale, administered by the clinician, measuring the occurrence and severity of 10 symptomatic dimensions of depression. For each dimension, a score between 0 (normal, no symptoms) to 6 (severely impaired) is reported. Single scores for each dimension are summed to obtain a total score (ranging from 0 to 60). | 6 months |
| Efficacy on depressive symptoms as assessed by the MADRS | Mean change scores at MADRS. The MADRS is a validated rating scale, administered by the clinician, measuring the occurrence and severity of 10 symptomatic dimensions of depression. For each dimension, a score between 0 (normal, no symptoms) to 6 (severely impaired) is reported. Single scores for each dimension are summed to obtain a total score (ranging from 0 to 60). | 6 months |
| Quality of life as assessed by the EQ-5D | Mean change scores at the EQ-5D. The EQ-5D is a validated rating scale, self-administered, measuring the quality of life according to 5 dimensions. In addition, the overall health status on the day of the interview is measured on a visual analogue scale ranging from 0 (worst possible health status) to 100 (best possible health status). When interpreting the scale, dimensions are to be considered separately and not summed in a total score. | 6 months |
| Cognitive performance as assessed by the SBT | Mean change scores at the Short Blessed Scale (SBT). The SBT is a validated rating scale, administered by the clinician, measuring the cognitive performance. The SBT is a screening tool that aids in detecting early cognitive changes associated with dementia disorders. Further testing is warranted if dementia is suspected, the SBT should not be used to diagnose dementia. This is a weighted six-item instrument that evaluates orientation, registration, and attention. | 6 months |
| Roma |
| Italy |
| Azienda Ospedaliera Universitaria Verona | Verona | 37134 | Italy |
| Derived |
| Bartoli F, Cavaleri D, Riboldi I, Callovini T, Crocamo C, Gastaldon C, Aguglia A, Callegari C, Cavallotti S, Chiappini S, Cruciata M, D'Agostino A, Espa I, Grassi L, Ielmini M, Mammarella S, Martinotti G, Rania M, Rodolico A, Roncone R, Roselli V, Segura-Garcia C, Signorelli MS, Tarsitani L; VESPA Study Group; Ostuzzi G, Carra G. Efficacy and Tolerability of Vortioxetine Versus Selective Serotonin Reuptake Inhibitors for Late-Life Depression: A Post-hoc Analysis of the VESPA Study. Drugs Aging. 2025 Aug;42(8):771-780. doi: 10.1007/s40266-025-01231-3. Epub 2025 Jul 18. |
| 38384338 | Derived | Ostuzzi G, Gastaldon C, Tettamanti M, Cartabia M, Monti I, Aguglia A, Aguglia E, Bartoli F, Callegari C, Canozzi A, Carbone EA, Carra G, Caruso R, Cavallotti S, Chiappini S, Colasante F, Compri B, D'Agostino A, De Fazio P, de Filippis R, Gari M, Ielmini M, Ingrosso G, Mammarella S, Martinotti G, Rodolico A, Roncone R, Sterzi E, Tarsitani L, Tiberto E, Todini L, Amaddeo F, D'Avanzo B; VESPA Study Group; Barbato A, Barbui C. Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trial. EClinicalMedicine. 2024 Feb 15;69:102491. doi: 10.1016/j.eclinm.2024.102491. eCollection 2024 Mar. |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| D020280 | Sertraline |
| D015283 | Citalopram |
| D000089983 | Escitalopram |
| D017374 | Paroxetine |
| D005473 | Fluoxetine |
| D016666 | Fluvoxamine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011437 | Propylamines |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010880 | Piperidines |
| D010091 | Oximes |
| D006898 | Hydroxylamines |
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