<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03779789</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0234923</org_study_id>
    <secondary_id>2018-001444-66</secondary_id>
    <nct_id>NCT03779789</nct_id>
  </id_info>
  <brief_title>Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment</brief_title>
  <acronym>VESPA</acronym>
  <official_title>Assessing Tolerability and Efficacy of Vortioxetine Versus SSRIs in Elderly Patients With Depression: a Pragmatic, Multicenter, Open-label, Parallel-group, Superiority, Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera Universitaria Integrata Verona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Catania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda Ospedaliera Universitaria Integrata Verona</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background. Depression is a highly frequent condition in the elderly, with a huge impact on&#xD;
      quality of life, life expectancy, and medical outcomes. SSRIs are commonly prescribed in&#xD;
      elderly depressed patients and, although generally safe, they may be associated with&#xD;
      tolerability issues. Based on available studies, vortioxetine is likely to have a promising&#xD;
      tolerability profile in the elderly, as it does not adversely affect psychomotor or cognitive&#xD;
      performance, wakefulness, body weight, and electrocardiogram parameters.&#xD;
&#xD;
      Objectives. Assessing the comparative tolerability, safety and efficacy of vortioxetine&#xD;
      compared with the SSRIs as a group (including sertraline, citalopram, escitalopram,&#xD;
      paroxetine, fluoxetine, fluvoxamine) in elderly patients affected by major depression. The&#xD;
      primary outcome will be the withdrawal rate due to adverse events.&#xD;
&#xD;
      Methods. This is a pragmatic, multicenter, open-label, parallel-group, superiority,&#xD;
      randomized trial. Twelve Italian Community Psychiatric Services will consecutively enrol&#xD;
      elderly patients suffering from an episode of major depression who get in contact over a&#xD;
      period of 12 months. By employing the web-based application RedCap, doctors will be able to&#xD;
      randomize patients to vortioxetine or one of the SSRIs, chosen on the basis of clinical&#xD;
      judgment, and to collect basic socio-demographic and clinical data. Trained and blinded&#xD;
      assessors will administer five validated rating scales: Montgomery-Åsberg Depression Rating&#xD;
      Scale (MADRS), Antidepressant Side-Effect Checklist (ASEC), EuroQual 5 Dimensions (EQ-5D),&#xD;
      Charlson Age-Comorbidity Index (CACI), and Short Blessed Test (SBT). Patients will be&#xD;
      assessed after 1, 3 and 6 months.&#xD;
&#xD;
      Expected results. On the basis of current literature, the investigators hypothesize&#xD;
      vortioxetine to be superior to SSRIs as a group in terms of tolerability. As vortioxetine is&#xD;
      expected to reduce the withdrawal rates due to adverse events of about 12% compared to SSRIs,&#xD;
      and assuming that about 23% of the participants could be lost within 6 months, the&#xD;
      investigators aim to enrol 358 patients (179 in each group).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">February 28, 2023</completion_date>
  <primary_completion_date type="Actual">February 28, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Pragmatic, multicenter, open-label, parallel-group, superiority, randomized trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants withdrawing from treatment due to adverse events (tolerability)</measure>
    <time_frame>6 months</time_frame>
    <description>Participants withdrawing from allocated treatment due to adverse events on the number of randomized patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants withdrawing from treatment due to any cause (acceptability)</measure>
    <time_frame>6 months</time_frame>
    <description>Participants withdrawing from allocated treatment due to any cause on the number of randomized patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall mortality</measure>
    <time_frame>6 months</time_frame>
    <description>The number of deaths on the number of randomized patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with at least one episode of self-harm</measure>
    <time_frame>6 months</time_frame>
    <description>Number of participants with at least one episode of self-harm on the number of randomized patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants died by suicide</measure>
    <time_frame>6 months</time_frame>
    <description>Number of participants died by suicide on the number of randomized patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-related adverse events as assessed by the ASEC</measure>
    <time_frame>6 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with a reduction of at least 50% of the baseline score of the MADRS (responders)</measure>
    <time_frame>6 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy on depressive symptoms as assessed by the MADRS</measure>
    <time_frame>6 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life as assessed by the EQ-5D</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive performance as assessed by the SBT</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">362</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>vortioxetine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SSRIs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vortioxetine</intervention_name>
    <description>Antidepressant classified under the category &quot;other antidepressants&quot; 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).</description>
    <arm_group_label>vortioxetine</arm_group_label>
    <other_name>Brintellix</other_name>
    <other_name>Trintellix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sertraline</intervention_name>
    <description>Antidepressant classified under the category &quot;Selective serotonin reuptake inhibitors&quot; 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).</description>
    <arm_group_label>SSRIs</arm_group_label>
    <other_name>Zoloft</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>citalopram</intervention_name>
    <description>Antidepressant classified under the category &quot;Selective serotonin reuptake inhibitors&quot; 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).</description>
    <arm_group_label>SSRIs</arm_group_label>
    <other_name>Elopram</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Escitalopram</intervention_name>
    <description>Antidepressant classified under the category &quot;Selective serotonin reuptake inhibitors&quot; 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).</description>
    <arm_group_label>SSRIs</arm_group_label>
    <other_name>Entact</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paroxetine</intervention_name>
    <description>Antidepressant classified under the category &quot;Selective serotonin reuptake inhibitors&quot; 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).</description>
    <arm_group_label>SSRIs</arm_group_label>
    <other_name>Daparox</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluoxetine</intervention_name>
    <description>Antidepressant classified under the category &quot;Selective serotonin reuptake inhibitors&quot; 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).</description>
    <arm_group_label>SSRIs</arm_group_label>
    <other_name>Prozac</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluvoxamine</intervention_name>
    <description>Antidepressant classified under the category &quot;Selective serotonin reuptake inhibitors&quot; 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).</description>
    <arm_group_label>SSRIs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 65 years old or above;&#xD;
&#xD;
          2. willing to participate by signing an informed consent;&#xD;
&#xD;
          3. suffering from an episode of major depression, based on clinical judgment (guided by&#xD;
             DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)&#xD;
             criteria);&#xD;
&#xD;
          4. treatment with an antidepressant is clinically appropriate, based on clinical/medical&#xD;
             judgment;&#xD;
&#xD;
          5. agreement between investigator and patient to discontinue any current antidepressant,&#xD;
             second generation antipsychotic, or lithium. According to the pragmatic design of the&#xD;
             study, the discontinuation will be performed according to common routine practice. No&#xD;
             specific protocols for discontinuation will be applied. All other concomitant&#xD;
             medications are allowed;&#xD;
&#xD;
          6. uncertainty about which trial treatment would be best for the participant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. dementia, of any type and stage, as formally diagnosed by a specialist (geriatrician,&#xD;
             neurologist, or others);&#xD;
&#xD;
          2. diagnosis of schizophrenia or bipolar disorder;&#xD;
&#xD;
          3. clinical conditions or treatments which contraindicate the use of oral vortioxetine or&#xD;
             SSRIs, according to clinical/medical judgment (for example conditions or treatments at&#xD;
             high risk of bleeding, convulsions, serotoninergic syndrome, hyponatraemia, etc.). All&#xD;
             concomitant medications will be prescribed according to routine clinical practice, in&#xD;
             compliance with the synthesis of the product characteristics (Riassunto delle&#xD;
             Caratteristiche del Prodotto - RCP) registered in the databank of the AIFA (Agenzia&#xD;
             Italiana del Farmaco) (available at&#xD;
             https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/cerca-farmaco).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Mater Domini, Università Magna Grecia</name>
      <address>
        <city>Catanzaro</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sapienza Università di Roma, Dipartimento di Neurologia e Psichiatria</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Verona</name>
      <address>
        <city>Verona</city>
        <zip>37134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>32746941</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 18, 2023</last_update_submitted>
  <last_update_submitted_qc>May 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vortioxetine</keyword>
  <keyword>SSRI</keyword>
  <keyword>depression</keyword>
  <keyword>elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vortioxetine</mesh_term>
    <mesh_term>Fluvoxamine</mesh_term>
    <mesh_term>Citalopram</mesh_term>
    <mesh_term>Fluoxetine</mesh_term>
    <mesh_term>Paroxetine</mesh_term>
    <mesh_term>Sertraline</mesh_term>
    <mesh_term>Escitalopram</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779789
org study id: 2016-0234923
secondary id: 2018-001444-66
nct id: NCT03779789
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pragmatic, multicenter, open-label, parallel-group, superiority, randomized trial.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Number of participants withdrawing from treatment due to adverse events (tolerability)
time frame: 6 months
description: Participants withdrawing from allocated treatment due to adverse events on the number of randomized patients.
measure: Number of participants withdrawing from treatment due to any cause (acceptability)
time frame: 6 months
description: Participants withdrawing from allocated treatment due to any cause on the number of randomized patients
measure: Overall mortality
time frame: 6 months
description: The number of deaths on the number of randomized patients
measure: Number of participants with at least one episode of self-harm
time frame: 6 months
description: Number of participants with at least one episode of self-harm on the number of randomized patients
measure: Number of participants died by suicide
time frame: 6 months
description: Number of participants died by suicide on the number of randomized patients
measure: Treatment-related adverse events as assessed by the ASEC
time frame: 6 months
description: 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).
measure: Number of participants with a reduction of at least 50% of the baseline score of the MADRS (responders)
time frame: 6 months
description: 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).
measure: Efficacy on depressive symptoms as assessed by the MADRS
time frame: 6 months
description: 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).
measure: Quality of life as assessed by the EQ-5D
time frame: 6 months
description: 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.
measure: Cognitive performance as assessed by the SBT
time frame: 6 months
description: 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.
arm group label: vortioxetine
arm group type: Experimental
arm group label: SSRIs
arm group type: Active Comparator
intervention type: Drug
intervention name: Vortioxetine
description: 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).
arm group label: vortioxetine
other name: Brintellix
other name: Trintellix
intervention type: Drug
intervention name: Sertraline
description: 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).
arm group label: SSRIs
other name: Zoloft
intervention type: Drug
intervention name: citalopram
description: 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).
arm group label: SSRIs
other name: Elopram
intervention type: Drug
intervention name: Escitalopram
description: 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).
arm group label: SSRIs
other name: Entact
intervention type: Drug
intervention name: Paroxetine
description: 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).
arm group label: SSRIs
other name: Daparox
intervention type: Drug
intervention name: Fluoxetine
description: 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).
arm group label: SSRIs
other name: Prozac
intervention type: Drug
intervention name: Fluvoxamine
description: 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).
arm group label: SSRIs
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: Italy
citation: 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.
PMID: 32746941
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
mesh term: Vortioxetine
mesh term: Fluvoxamine
mesh term: Citalopram
mesh term: Fluoxetine
mesh term: Paroxetine
mesh term: Sertraline
mesh term: Escitalopram
sharing ipd: Undecided