<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/NCT03841474</url>
  </required_header>
  <id_info>
    <org_study_id>KBC Zagreb CoroDep</org_study_id>
    <nct_id>NCT03841474</nct_id>
  </id_info>
  <brief_title>The Recovery of Cardiovascular Patients With Depression</brief_title>
  <official_title>The Changes in Functional Recovery and Brain Neurotrophic Factor Six Months After Percutaneous Coronary Intervention in Cardiovascular Patients With Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klinički Bolnički Centar Zagreb</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Klinički Bolnički Centar Zagreb</source>
  <oversight_info>
    <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>
      Cardiovascular disease increases the risk of depression and vice versa. Many cardiovascular&#xD;
      patients are subjected to percutaneous coronary intervention (PCI). Potential biomarkers for&#xD;
      the development, the course and the recovery of both diseases are in the focus of interest of&#xD;
      many studies. One of the biomarkers that stands out is brain derived neurotrophic factor&#xD;
      (BDFN). BDNF plays a significant role in regulating vascular growth and repair but also&#xD;
      stimulates the survival, differentiation, and conservation of neurons.&#xD;
&#xD;
      The aim of the study is to detect the depression in patients undergoing PCI and to determine&#xD;
      the impact of psychiatric treatment on the functional recovery and on the changes of BDNF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It has been shown that cardiovascular disease increases the risk of depression and vice&#xD;
      versa. A significant proportion of cardiovascular diseases are coronary artery disease; most&#xD;
      of these patients are subjected to percutaneous coronary intervention (PCI). That population&#xD;
      of patients, which is under greater risk of depression, has been passing through the health&#xD;
      system without adequate management of psychiatric difficulties. Despite the abundance of the&#xD;
      data regarding the concomitancy of cardiovascular disease and depression, potential&#xD;
      biomarkers for the development, the course and the recovery of both diseases are still in the&#xD;
      focus of interest of many studies. One of the biomarkers that stands out is brain derived&#xD;
      neurotrophic factor (BDFN). BDNF plays a significant role in regulating vascular growth and&#xD;
      repair but also stimulates the survival, differentiation, and conservation of neurons. Its'&#xD;
      serum level is reduced in cardiac failure and acute coronary syndrome, and indicates a higher&#xD;
      risk of coronary incident in angina pectoris. BDNF is also reduced in depression, but&#xD;
      increases during a pharmacological treatment along with the clinical improvement.&#xD;
&#xD;
      Therefore the aim of the study is to detect the occurrence of depression in patients&#xD;
      undergoing PCI and to determine the impact of psychiatric treatment on the functional&#xD;
      recovery of those patient and the correlation with the changes of serum levels of BDNF.&#xD;
&#xD;
      This represents the objectivization of the tertiary type of prevention intervention for&#xD;
      recovery of cardiovascular patients who are currently passing through the investigator's&#xD;
      health system with unrecognized psychiatric comorbidity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2021</start_date>
  <completion_date type="Anticipated">November 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients will be assigned to intervention group if they have symptoms of depression, i.e. to control group if they do not show depressive symptoms.&#xD;
A psychiatrist will then, according to clinical impression, prescribe either sertraline or escitalopram to intervention group (i.e. groups). Both groups (sertraline and escitalopram) will be described as one intervention group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Montgomery Asberg Depression Scale (MADRS) at 6 months</measure>
    <time_frame>baseline, six months</time_frame>
    <description>A 10-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Ten questions rate the severity of symptoms on scale of 0 (not present), 2 (mild), 4 (moderate), and 6 (severe).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Hamilton Rating Scale for Depression (HAM-D) at 6 months</measure>
    <time_frame>baseline, six months</time_frame>
    <description>Semi-structured interview with 17 questions, designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. A score of 0-7 is considered to be normal while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Beck Depression Inventory (BDI) at 6 months</measure>
    <time_frame>baseline, six months</time_frame>
    <description>A 21-question multiple-choice self-report inventory, with each question having a set of four and more possible responses, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score represents the sum of the values. Higher total score indicates more severe depressive symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline EuroQol Group 3-level version instrument (EQ-5D-3L) at 6 months</measure>
    <time_frame>baseline, six month</time_frame>
    <description>EQ-5D is a standardized instrument for measuring generic health status. Questionnaire has five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and all dimensions are described by 3 problem levels corresponding to patient response choices. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline The Global Registry of Acute Coronary Events (GRACE ACS Risk Model) at 6 months</measure>
    <time_frame>baseline, six months</time_frame>
    <description>Changes in GRACE ACS Risk Model of cardiovascular patients six months after PCI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Duke Activity Status Index (DASI) at 6 months</measure>
    <time_frame>baseline, six months</time_frame>
    <description>The Duke Activity Status Index (DASI) is an a 12-item questionnaire assessment tool used to evaluate the functional capacity of patients with cardiovascular disease. Each item has a specific weight based on the metabolic cost. The final score ranges between zero and 58.2 points. The higher the score indicates better functional capacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline The Seattle Angina Questionnaire (SAQ-7) at 6 months</measure>
    <time_frame>baseline, six months</time_frame>
    <description>SAQ is a 19-item instrument that measures patient-reported symptoms, function and quality of life for patients with coronary artery disease. The answers patients give to the SAQ's questions are used to calculate scores in five scales: anginal stability, anginal frequency, physical limitation, treatment satisfaction and quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of blood serum concentrations of brain derived neurotrophic factor (BDNF) at 6 months</measure>
    <time_frame>baseline, six months</time_frame>
    <description>Changes in the serum levels of BDNF six months after PCI in cardiovascular patients without and cardiovascular patients with depressive symptoms</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Depression</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Intervention I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Psychiatric treatment with sertraline (range from 50 mg/day to 200mg/day according to clinical appearance) of cardiovascular patients after PCI with mild, moderate or severe depression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Cardiovascular patients after PCI without depressive symptoms and without the need for psychiatric intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Psychiatric treatment with escitalopram (range from 10 mg/day to 20 mg/day according to clinical appearance) of cardiovascular patients after PCI with mild, moderate or severe depression</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Psychiatric treatment with sertraline</intervention_name>
    <description>Psychiatric treatment with sertraline (range from 50 mg/day to 200mg/day according to clinical appearance) of newly recognized depression in patients after PCI</description>
    <arm_group_label>Intervention I</arm_group_label>
    <other_name>Intervention I</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Psychiatric treatment with escitalopram</intervention_name>
    <description>Psychiatric treatment with escitalopram (range from 10 mg/day to 20 mg/day according to clinical appearance) of newly recognized depression in patients after PCI</description>
    <arm_group_label>Intervention II</arm_group_label>
    <other_name>Intervention II</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients on day of percutaneous coronary intervention due to angina pectoris or&#xD;
             myocardial infarction&#xD;
&#xD;
          -  without antidepressant drugs or major tranquilizers more than one year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  symptoms of myocardial infarction lasting more than 12 hours&#xD;
&#xD;
          -  left ventricle ejection function (LVEF) less than 40%&#xD;
&#xD;
          -  earlier presence of cardiomyopathy&#xD;
&#xD;
          -  acute infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alma Mihaljević Peleš, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Head of Department of Psychiatry</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sara Medved, MD</last_name>
    <phone>+38512388394</phone>
    <email>smedved@kbc-zagreb.hr</email>
  </overall_contact>
  <location>
    <facility>
      <name>KBC Zagreb</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Medved, MD</last_name>
      <phone>+38512388394</phone>
      <email>smedved@kbc-zagreb.hr</email>
    </contact>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 17, 2021</last_update_submitted>
  <last_update_submitted_qc>February 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Klinički Bolnički Centar Zagreb</investigator_affiliation>
    <investigator_full_name>Sara Medved</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Brain derived neurotrophic factor</keyword>
  <keyword>BDNF</keyword>
  <keyword>Psychosocial indicators</keyword>
  <keyword>Depression</keyword>
  <keyword>Cardiovascular disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sertraline</mesh_term>
    <mesh_term>Escitalopram</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/NCT03841474
org study id: KBC Zagreb CoroDep
nct id: NCT03841474
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Cardiovascular disease increases the risk of depression and vice versa. Many cardiovascular
      patients are subjected to percutaneous coronary intervention (PCI). Potential biomarkers for
      the development, the course and the recovery of both diseases are in the focus of interest of
      many studies. One of the biomarkers that stands out is brain derived neurotrophic factor
      (BDFN). BDNF plays a significant role in regulating vascular growth and repair but also
      stimulates the survival, differentiation, and conservation of neurons.

      The aim of the study is to detect the depression in patients undergoing PCI and to determine
      the impact of psychiatric treatment on the functional recovery and on the changes of BDNF.
It has been shown that cardiovascular disease increases the risk of depression and vice
      versa. A significant proportion of cardiovascular diseases are coronary artery disease; most
      of these patients are subjected to percutaneous coronary intervention (PCI). That population
      of patients, which is under greater risk of depression, has been passing through the health
      system without adequate management of psychiatric difficulties. Despite the abundance of the
      data regarding the concomitancy of cardiovascular disease and depression, potential
      biomarkers for the development, the course and the recovery of both diseases are still in the
      focus of interest of many studies. One of the biomarkers that stands out is brain derived
      neurotrophic factor (BDFN). BDNF plays a significant role in regulating vascular growth and
      repair but also stimulates the survival, differentiation, and conservation of neurons. Its'
      serum level is reduced in cardiac failure and acute coronary syndrome, and indicates a higher
      risk of coronary incident in angina pectoris. BDNF is also reduced in depression, but
      increases during a pharmacological treatment along with the clinical improvement.

      Therefore the aim of the study is to detect the occurrence of depression in patients
      undergoing PCI and to determine the impact of psychiatric treatment on the functional
      recovery of those patient and the correlation with the changes of serum levels of BDNF.

      This represents the objectivization of the tertiary type of prevention intervention for
      recovery of cardiovascular patients who are currently passing through the investigator's
      health system with unrecognized psychiatric comorbidity.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be assigned to intervention group if they have symptoms of depression, i.e. to control group if they do not show depressive symptoms.
A psychiatrist will then, according to clinical impression, prescribe either sertraline or escitalopram to intervention group (i.e. groups). Both groups (sertraline and escitalopram) will be described as one intervention group.
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline Montgomery Asberg Depression Scale (MADRS) at 6 months
time frame: baseline, six months
description: A 10-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Ten questions rate the severity of symptoms on scale of 0 (not present), 2 (mild), 4 (moderate), and 6 (severe).
measure: Change from Baseline Hamilton Rating Scale for Depression (HAM-D) at 6 months
time frame: baseline, six months
description: Semi-structured interview with 17 questions, designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. A score of 0-7 is considered to be normal while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.
measure: Change from Baseline Beck Depression Inventory (BDI) at 6 months
time frame: baseline, six months
description: A 21-question multiple-choice self-report inventory, with each question having a set of four and more possible responses, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score represents the sum of the values. Higher total score indicates more severe depressive symptoms.
measure: Change from Baseline EuroQol Group 3-level version instrument (EQ-5D-3L) at 6 months
time frame: baseline, six month
description: EQ-5D is a standardized instrument for measuring generic health status. Questionnaire has five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and all dimensions are described by 3 problem levels corresponding to patient response choices. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale.
measure: Change from Baseline The Global Registry of Acute Coronary Events (GRACE ACS Risk Model) at 6 months
time frame: baseline, six months
description: Changes in GRACE ACS Risk Model of cardiovascular patients six months after PCI
measure: Change from Baseline Duke Activity Status Index (DASI) at 6 months
time frame: baseline, six months
description: The Duke Activity Status Index (DASI) is an a 12-item questionnaire assessment tool used to evaluate the functional capacity of patients with cardiovascular disease. Each item has a specific weight based on the metabolic cost. The final score ranges between zero and 58.2 points. The higher the score indicates better functional capacity.
measure: Change from Baseline The Seattle Angina Questionnaire (SAQ-7) at 6 months
time frame: baseline, six months
description: SAQ is a 19-item instrument that measures patient-reported symptoms, function and quality of life for patients with coronary artery disease. The answers patients give to the SAQ's questions are used to calculate scores in five scales: anginal stability, anginal frequency, physical limitation, treatment satisfaction and quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better functioning.
measure: Changes of blood serum concentrations of brain derived neurotrophic factor (BDNF) at 6 months
time frame: baseline, six months
description: Changes in the serum levels of BDNF six months after PCI in cardiovascular patients without and cardiovascular patients with depressive symptoms
arm group label: Intervention I
arm group type: Experimental
description: Psychiatric treatment with sertraline (range from 50 mg/day to 200mg/day according to clinical appearance) of cardiovascular patients after PCI with mild, moderate or severe depression
arm group label: Control
arm group type: No Intervention
description: Cardiovascular patients after PCI without depressive symptoms and without the need for psychiatric intervention
arm group label: Intervention II
arm group type: Experimental
description: Psychiatric treatment with escitalopram (range from 10 mg/day to 20 mg/day according to clinical appearance) of cardiovascular patients after PCI with mild, moderate or severe depression
intervention type: Drug
intervention name: Psychiatric treatment with sertraline
description: Psychiatric treatment with sertraline (range from 50 mg/day to 200mg/day according to clinical appearance) of newly recognized depression in patients after PCI
arm group label: Intervention I
other name: Intervention I
intervention type: Drug
intervention name: Psychiatric treatment with escitalopram
description: Psychiatric treatment with escitalopram (range from 10 mg/day to 20 mg/day according to clinical appearance) of newly recognized depression in patients after PCI
arm group label: Intervention II
other name: Intervention II
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Alma Mihaljević Peleš, Prof.
role: Study Chair
affiliation: Head of Department of Psychiatry
last name: Sara Medved, MD
phone: +38512388394
email: smedved@kbc-zagreb.hr
facility: 
status: Recruiting
contact: 
country: Croatia
responsible party type: Principal Investigator
investigator affiliation: Klinički Bolnički Centar Zagreb
investigator full name: Sara Medved
investigator title: Principal Investigator
mesh term: Cardiovascular Diseases
mesh term: Coronary Artery Disease
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Sertraline
mesh term: Escitalopram
sharing ipd: No