<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/NCT04456777</url>
  </required_header>
  <id_info>
    <org_study_id>evcps</org_study_id>
    <nct_id>NCT04456777</nct_id>
  </id_info>
  <brief_title>Effect of Vortioxetine on Cognitive Symptoms in Patients With Schizophrenia</brief_title>
  <official_title>Effect of Vortioxetine on Cognitive Symptoms in Patients With</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alen Greš</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Hospital Centre Zagreb</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Research goals:&#xD;
&#xD;
        1. Examination of the relationship between the use of vortioxetine and cognitive efficacy&#xD;
           in patients with schizophrenia.&#xD;
&#xD;
        2. Examination of the association between the use of vortioxetine and the presence&#xD;
           depressive symptoms, physical and social anhedonia in patients with the disease from&#xD;
           schizophrenia.&#xD;
&#xD;
        3. Examining the association between vortioxetine use and quality of life&#xD;
&#xD;
      (functional recovery) in patients with schizophrenia&#xD;
&#xD;
      Expected results (hypotheses)&#xD;
&#xD;
        1. Patients with schizophrenia treated with additional therapy vortioxetine will show&#xD;
           better cognitive achievement in memory (short-term and long-term), attention, logical&#xD;
           reasoning and reasoning, speed of information processing, processing of visual and sound&#xD;
           information, language and speech in relation to patients without additional&#xD;
           intervention.&#xD;
&#xD;
        2. Patients with schizophrenia treated with additional therapy vortioxetine will have a&#xD;
           less pronounced presence of depressive symptoms, physical and social anhedonia in&#xD;
           relation to untreated patients with additional vortioxetine therapy.&#xD;
&#xD;
        3. Patients with schizophrenia who were treated with additional therapy vortioxetine will&#xD;
           have a better quality of life, ie. better functional recovery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the first phase of the research, the development of the research protocol and obtaining it&#xD;
      will be done of his approval.&#xD;
&#xD;
      The second phase of the research will include patients with schizophrenia disorders based on&#xD;
      inclusive and exclusive criteria and a study will be conducted procedure. In the third phase&#xD;
      of the research, the obtained results are processed and analyzed.&#xD;
&#xD;
      The content of the dissertation will include an introduction, a goal with hypotheses,&#xD;
      methods, results, discussion, conclusions and literature. In the introduction, in addition to&#xD;
      current knowledge about schizophrenia and vortioxetine, it will be pointed out cognition&#xD;
      problem in patients with schizophrenia.&#xD;
&#xD;
      It will be defined and explained hypotheses and research objectives. In the chapter dedicated&#xD;
      to methodology, the number of respondents and a description will be presented study concepts,&#xD;
      presentation of statistical methods used for data processing The presentation of the results&#xD;
      obtained by this study will be presented textually, tabularly and using charts. The obtained&#xD;
      results will be commented and evaluated in the Discussion. Recent literature will be used&#xD;
&#xD;
      Randomization 1:1 will divide 120 patients with schizophrenia into two groups, each group&#xD;
      into 3 subgroups. One group of 60 patients (who are on monotherapy antipsychotics: new&#xD;
      generations: 20 patients will be on olanzapine, 20 patients on risperidone and 20 patients on&#xD;
      aripiprazole) will receive vortioxetine and the other control group of 60 patients (who is&#xD;
      also on monotherapy with new antipsychotics generations: 20 patients will be on olanzapine,&#xD;
      20 patients on risperidone and 20 patients on aripiprazole) will not receive vortioxetine.&#xD;
      Vortioxetine will be given in 10 mg dose (which can be reduced by 5 mg if needed in case of&#xD;
      poor tolerability)&#xD;
&#xD;
        1. Initial examination:&#xD;
&#xD;
           International mini neuropsychiatric interview (M.I.N.I.) publicly available, works&#xD;
           doctor General questionnaire - designed by a doctor Positive and negative syndrome&#xD;
           scales (PANSS) are publicly available, by a doctor The Calgary Depression Scale for&#xD;
           Schizophrenia (CDSS) is publicly available, it works doctor World Health Organization&#xD;
           for Quality of Life (WHOQOL-BREF) publicly available, works doctor Chapman (social&#xD;
           anhedonia and physical anhedonia) - publicly available, works doctor Wechsler WAIS IV&#xD;
           (subtests: numerical memory test; encryption test symbols) - available at Naklada Slap,&#xD;
           Zagreb, HR, by a clinical psychologist&#xD;
&#xD;
           Screening tests:&#xD;
&#xD;
             1. Mini-mental state (MMSE) or Folstein test - publicly available, by a doctor&#xD;
&#xD;
             2. Montreal Cognitive Assessment (MoCA) - publicly available, by a physician&#xD;
&#xD;
        2. At the end of the second month:&#xD;
&#xD;
           International mini neuropsychiatric interview (M.I.N.I.) publicly available, works&#xD;
           doctor Mini-mental state (MMSE) or Folstein test - publicly available, by a doctor&#xD;
           Montreal Cognitive Assessment (MoCA) - publicly available, by a doctor&#xD;
&#xD;
        3. At the end of the third month:&#xD;
&#xD;
      International mini neuropsychiatric interview (M.I.N.I.) publicly available, works doctor&#xD;
      Positive and negative syndrome scales (PANSS) are publicly available, by a doctor The Calgary&#xD;
      Depression Scale for Schizophrenia (CDSS) is publicly available, it works doctor World Health&#xD;
      Organization for Quality of Life (WHOQOL-BREF) publicly available, works doctor Chapman&#xD;
      (social anhedonia and physical anhedonia) - publicly available, works doctor Wechsler WAIS IV&#xD;
      (subtests: numerical memory test; encryption test)&#xD;
&#xD;
      - Available at Naklada Slap, Zagreb, HR, by a clinical psychologist Screening tests: a)&#xD;
      Mini-mental state (MMSE) or Folstein test - public&#xD;
&#xD;
      available, works doctor b) Montreal Cognitive Assessment (MoCA) - publicly available, by a&#xD;
      doctor It is expected: improvement of cognitive functions in relation to the initial&#xD;
      examination&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2022</primary_completion_date>
  <phase>Early Phase 1</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>better cognitive functions</measure>
    <time_frame>2 years</time_frame>
    <description>improvement of cognitive functions compared to initial examination</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Cognitive Deficit</condition>
  <arm_group>
    <arm_group_label>1group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with vortioxetine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients without vortioxetine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vortioxetine</intervention_name>
    <description>vortioxetine will be administreted for 3 months</description>
    <arm_group_label>1group</arm_group_label>
    <arm_group_label>2 group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 50, informed consent signed, confirmed diagnosis of schizophrenia,&#xD;
             taking monotherapy with antipsychotics: aripiprazole, risperidone, paliperidone or&#xD;
             olanzapine, unchanged dose maintenance back at least 6 months, remission of psychotic&#xD;
             symptoms (PANSS ≤ 70), and that they do not have any of the exclusive criteria:&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  taking benzodiazepines at doses equivalent to ≥ 10 mg diazepam, taking mood&#xD;
             stabilizers, antidepressants three months ago, abuse of addictions back three months,&#xD;
             suicide attempt back 6 months, suicidal, heteroaggressive, or other similar behavior&#xD;
             back 6 months, somatic comorbidities affecting cognitive functions (intellectual&#xD;
             disabilities, significant neurological disease or head trauma), pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Alen Greš, MD</last_name>
    <phone>+385958845451</phone>
    <email>alengres@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marina Šagud, prof, MD</last_name>
    <email>marinasagud@mail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Centre Zagreb</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Hospital Centre Zagreb</investigator_affiliation>
    <investigator_full_name>Alen Greš</investigator_full_name>
    <investigator_title>Alen Greš,MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurobehavioral Manifestations</mesh_term>
    <mesh_term>Cognition Disorders</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vortioxetine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04456777
org study id: evcps
nct id: NCT04456777
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Research goals:

        1. Examination of the relationship between the use of vortioxetine and cognitive efficacy
           in patients with schizophrenia.

        2. Examination of the association between the use of vortioxetine and the presence
           depressive symptoms, physical and social anhedonia in patients with the disease from
           schizophrenia.

        3. Examining the association between vortioxetine use and quality of life

      (functional recovery) in patients with schizophrenia

      Expected results (hypotheses)

        1. Patients with schizophrenia treated with additional therapy vortioxetine will show
           better cognitive achievement in memory (short-term and long-term), attention, logical
           reasoning and reasoning, speed of information processing, processing of visual and sound
           information, language and speech in relation to patients without additional
           intervention.

        2. Patients with schizophrenia treated with additional therapy vortioxetine will have a
           less pronounced presence of depressive symptoms, physical and social anhedonia in
           relation to untreated patients with additional vortioxetine therapy.

        3. Patients with schizophrenia who were treated with additional therapy vortioxetine will
           have a better quality of life, ie. better functional recovery
In the first phase of the research, the development of the research protocol and obtaining it
      will be done of his approval.

      The second phase of the research will include patients with schizophrenia disorders based on
      inclusive and exclusive criteria and a study will be conducted procedure. In the third phase
      of the research, the obtained results are processed and analyzed.

      The content of the dissertation will include an introduction, a goal with hypotheses,
      methods, results, discussion, conclusions and literature. In the introduction, in addition to
      current knowledge about schizophrenia and vortioxetine, it will be pointed out cognition
      problem in patients with schizophrenia.

      It will be defined and explained hypotheses and research objectives. In the chapter dedicated
      to methodology, the number of respondents and a description will be presented study concepts,
      presentation of statistical methods used for data processing The presentation of the results
      obtained by this study will be presented textually, tabularly and using charts. The obtained
      results will be commented and evaluated in the Discussion. Recent literature will be used

      Randomization 1:1 will divide 120 patients with schizophrenia into two groups, each group
      into 3 subgroups. One group of 60 patients (who are on monotherapy antipsychotics: new
      generations: 20 patients will be on olanzapine, 20 patients on risperidone and 20 patients on
      aripiprazole) will receive vortioxetine and the other control group of 60 patients (who is
      also on monotherapy with new antipsychotics generations: 20 patients will be on olanzapine,
      20 patients on risperidone and 20 patients on aripiprazole) will not receive vortioxetine.
      Vortioxetine will be given in 10 mg dose (which can be reduced by 5 mg if needed in case of
      poor tolerability)

        1. Initial examination:

           International mini neuropsychiatric interview (M.I.N.I.) publicly available, works
           doctor General questionnaire - designed by a doctor Positive and negative syndrome
           scales (PANSS) are publicly available, by a doctor The Calgary Depression Scale for
           Schizophrenia (CDSS) is publicly available, it works doctor World Health Organization
           for Quality of Life (WHOQOL-BREF) publicly available, works doctor Chapman (social
           anhedonia and physical anhedonia) - publicly available, works doctor Wechsler WAIS IV
           (subtests: numerical memory test; encryption test symbols) - available at Naklada Slap,
           Zagreb, HR, by a clinical psychologist

           Screening tests:

             1. Mini-mental state (MMSE) or Folstein test - publicly available, by a doctor

             2. Montreal Cognitive Assessment (MoCA) - publicly available, by a physician

        2. At the end of the second month:

           International mini neuropsychiatric interview (M.I.N.I.) publicly available, works
           doctor Mini-mental state (MMSE) or Folstein test - publicly available, by a doctor
           Montreal Cognitive Assessment (MoCA) - publicly available, by a doctor

        3. At the end of the third month:

      International mini neuropsychiatric interview (M.I.N.I.) publicly available, works doctor
      Positive and negative syndrome scales (PANSS) are publicly available, by a doctor The Calgary
      Depression Scale for Schizophrenia (CDSS) is publicly available, it works doctor World Health
      Organization for Quality of Life (WHOQOL-BREF) publicly available, works doctor Chapman
      (social anhedonia and physical anhedonia) - publicly available, works doctor Wechsler WAIS IV
      (subtests: numerical memory test; encryption test)

      - Available at Naklada Slap, Zagreb, HR, by a clinical psychologist Screening tests: a)
      Mini-mental state (MMSE) or Folstein test - public

      available, works doctor b) Montreal Cognitive Assessment (MoCA) - publicly available, by a
      doctor It is expected: improvement of cognitive functions in relation to the initial
      examination
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: better cognitive functions
time frame: 2 years
description: improvement of cognitive functions compared to initial examination
arm group label: 1group
arm group type: Experimental
description: patients with vortioxetine
arm group label: 2 group
arm group type: Placebo Comparator
description: patients without vortioxetine
intervention type: Drug
intervention name: Vortioxetine
description: vortioxetine will be administreted for 3 months
arm group label: 1group
arm group label: 2 group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alen Greš, MD
phone: +385958845451
email: alengres@gmail.com
last name: Marina Šagud, prof, MD
email: marinasagud@mail.com
facility: 
status: Recruiting
country: Croatia
responsible party type: Sponsor-Investigator
investigator affiliation: Clinical Hospital Centre Zagreb
investigator full name: Alen Greš
investigator title: Alen Greš,MD
mesh term: Neurobehavioral Manifestations
mesh term: Cognition Disorders
mesh term: Cognitive Dysfunction
mesh term: Vortioxetine
sharing ipd: No