<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/NCT04446039</url>
  </required_header>
  <id_info>
    <org_study_id>B2061147</org_study_id>
    <secondary_id>CAR-BIG Study</secondary_id>
    <nct_id>NCT04446039</nct_id>
  </id_info>
  <brief_title>Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea</brief_title>
  <official_title>Comparison of Antidepressants in the Real-World: Retrospective Cohort Study Using Big Data</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to investigate medication utilization pattern and risk&#xD;
      of adverse outcomes among commonly used antidepressants by using nationwide claims database,&#xD;
      in order to assess overall clinical benefit of antidepressant therapy in real-world practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While there are many antidepressants from which physicians can select based on efficacy and&#xD;
      tolerability profile, evidence on effectiveness and safety outcomes of new antidepressants in&#xD;
      real clinical practice among Korean MDD population is limited.&#xD;
&#xD;
      Hence, this study will explore the following primary, secondary objectives using national&#xD;
      health insurance database :&#xD;
&#xD;
        1. Explore baseline characteristics and drug utilization patterns of 11 commonly used&#xD;
           antidepressant therapy during 90 days of acute treatment phase&#xD;
&#xD;
        2. Explore drug utilization patterns such as therapy changes, medication compliance and&#xD;
           recurrence relationship, and risk of adverse outcomes during maintenance phase&#xD;
&#xD;
        3. Choice of antidepressants and drug utilization patterns in patients with various&#xD;
           comorbidities&#xD;
&#xD;
        4. The relationship of non-pharmacologic treatment and discontinuation, medication&#xD;
           compliance&#xD;
&#xD;
        5. Choice of antidepressants by non-psychiatric specialty&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 4, 2022</start_date>
  <completion_date type="Actual">November 3, 2022</completion_date>
  <primary_completion_date type="Actual">November 3, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of antidepressants</measure>
    <time_frame>90 days</time_frame>
    <description>Proportion out of total prescriptions in the first 90 days from the index date (acute treatment phase) by gender, age groups (20, 21-64, 65)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dosage: Index date</measure>
    <time_frame>90 days</time_frame>
    <description>Initial dosages at the index date</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dosage: Acute treatment phase</measure>
    <time_frame>90 days</time_frame>
    <description>Average dosages during the first 90 days of treatment (acute treatment phase)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Persistence: Average length of treatment</measure>
    <time_frame>6 months</time_frame>
    <description>Average length of treatment of each index drugs (allowing 14 day permissible gap) will be calculated.&#xD;
-Switching, combination, augmentation, discontinuation will terminate the persistent period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Discontinuation</measure>
    <time_frame>90 days</time_frame>
    <description>Percentage of patients discontinued each index drug within first 90 days of index treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence</measure>
    <time_frame>90 days</time_frame>
    <description>For each index drug, adherence will be measured as percentage of drug possessed (measured by medication possession ratio) within 90 days of index treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recurrence</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of patients experiencing recurrence (as measured by inpatient episode, emergency room visit, or suicide attempt) within 6 months of treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse outcomes</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of adverse events (as measured by GI bleeding, fractures, falls, intracranial hemorrhage, suicide attempt, self-harm, myocardial infarction, epilepsy/seizures, stroke, hyponatremia) within 6 months of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Drug utilization pattern in acute phase</measure>
    <time_frame>90 days</time_frame>
    <description>Percentage of patients on monotherapy, combination therapy, augmentation therapy during 90 days of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug utilization pattern in maintenance phase</measure>
    <time_frame>90 days</time_frame>
    <description>Precentage of patients on monotherapy, combination therapy, augmentation therapy during 90-180 days of treatment</description>
  </secondary_outcome>
  <number_of_groups>11</number_of_groups>
  <enrollment type="Actual">405349</enrollment>
  <condition>Major Depression</condition>
  <arm_group>
    <arm_group_label>1. Escitalopram Cohort</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>2. Paroxetine Cohort</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>3. Fluoxetine Cohort</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>4. Mirtazapine Cohort</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>5. Duloxetine Cohort</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>6. Sertraline Cohort</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>7. Venlafaxine Cohort</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>8. Tianeptine Cohort</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>9. Vortioxetine Cohort</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>10. Desvenlafaxine Cohort</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>11. Bupropion Cohort</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Escitalopram</intervention_name>
    <description>Treatment for depression</description>
    <arm_group_label>1. Escitalopram Cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paroxetine</intervention_name>
    <description>Treatment for depression</description>
    <arm_group_label>2. Paroxetine Cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluoxetine</intervention_name>
    <description>Treatment for depression</description>
    <arm_group_label>3. Fluoxetine Cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mirtazapine</intervention_name>
    <description>Treatment for depression</description>
    <arm_group_label>4. Mirtazapine Cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duloxetine</intervention_name>
    <description>Treatment for depression</description>
    <arm_group_label>5. Duloxetine Cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sertraline</intervention_name>
    <description>Treatment for depression</description>
    <arm_group_label>6. Sertraline Cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venlafaxine</intervention_name>
    <description>Treatment for depression</description>
    <arm_group_label>7. Venlafaxine Cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tianeptine</intervention_name>
    <description>Treatment for depression</description>
    <arm_group_label>8. Tianeptine Cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vortioxetine</intervention_name>
    <description>Treatment for depression</description>
    <arm_group_label>9. Vortioxetine Cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desvenlafaxine</intervention_name>
    <description>Treatment for depression</description>
    <arm_group_label>10. Desvenlafaxine Cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupropion</intervention_name>
    <description>Treatment for depression</description>
    <arm_group_label>11. Bupropion Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who newly initiated antidepressant therapies between Jan 01, 2017 to Jun 30, 2018&#xD;
        in the National Health Insurance Service (NHIS) database&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Patients must meet all of the following inclusion criteria to be eligible for inclusion in&#xD;
        the study:&#xD;
&#xD;
          1. Patients aged 18 years or older on the index date&#xD;
&#xD;
          2. Patients who had at least one inpatient claim or two outpatient claims in the intake&#xD;
             period with any of the following diagnosis codes F06.3 Organic mood [affective]&#xD;
             disorders F32* Depressive episode F33* Recurrent depressive disorder F34.1 Neurotic&#xD;
             depression F38.1 Other recurrent mood [affective] disorder F41.2 Mixed anxiety and&#xD;
             depressive disorder&#xD;
&#xD;
          3. Patients prescribed any of the following antidepressant during intake period (from&#xD;
             January 1, 2017 to June 30, 2018)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        Patients meeting any of the following criteria will not be included in the study:&#xD;
&#xD;
          1. Patients with a claim of diagnosis codes in Table 1 during the 12 month pre-index&#xD;
             period&#xD;
&#xD;
          2. Patients with a claim of prescription in Table 2 during the 12 month pre-index period&#xD;
&#xD;
          3. Patient who had a claim as a beneficiary of Medical Aid program (Korean Medicaid&#xD;
             program with free or minimum copay)&#xD;
&#xD;
          4. Patients who are hospitalized at the index date&#xD;
&#xD;
          5. Patients who are under hospice care (procedure codes WG*-WO*)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pfizer</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=B2061147</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>November 14, 2022</last_update_submitted>
  <last_update_submitted_qc>November 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Duloxetine Hydrochloride</mesh_term>
    <mesh_term>Vortioxetine</mesh_term>
    <mesh_term>Mirtazapine</mesh_term>
    <mesh_term>Bupropion</mesh_term>
    <mesh_term>Fluoxetine</mesh_term>
    <mesh_term>Paroxetine</mesh_term>
    <mesh_term>Venlafaxine Hydrochloride</mesh_term>
    <mesh_term>Sertraline</mesh_term>
    <mesh_term>Desvenlafaxine Succinate</mesh_term>
    <mesh_term>Tianeptine</mesh_term>
    <mesh_term>Escitalopram</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </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/NCT04446039
org study id: B2061147
secondary id: CAR-BIG Study
nct id: NCT04446039
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The primary purpose of this study is to investigate medication utilization pattern and risk
      of adverse outcomes among commonly used antidepressants by using nationwide claims database,
      in order to assess overall clinical benefit of antidepressant therapy in real-world practice.
While there are many antidepressants from which physicians can select based on efficacy and
      tolerability profile, evidence on effectiveness and safety outcomes of new antidepressants in
      real clinical practice among Korean MDD population is limited.

      Hence, this study will explore the following primary, secondary objectives using national
      health insurance database :

        1. Explore baseline characteristics and drug utilization patterns of 11 commonly used
           antidepressant therapy during 90 days of acute treatment phase

        2. Explore drug utilization patterns such as therapy changes, medication compliance and
           recurrence relationship, and risk of adverse outcomes during maintenance phase

        3. Choice of antidepressants and drug utilization patterns in patients with various
           comorbidities

        4. The relationship of non-pharmacologic treatment and discontinuation, medication
           compliance

        5. Choice of antidepressants by non-psychiatric specialty
observational model: Cohort
time perspective: Retrospective
measure: Proportion of antidepressants
time frame: 90 days
description: Proportion out of total prescriptions in the first 90 days from the index date (acute treatment phase) by gender, age groups (20, 21-64, 65)
measure: Dosage: Index date
time frame: 90 days
description: Initial dosages at the index date
measure: Dosage: Acute treatment phase
time frame: 90 days
description: Average dosages during the first 90 days of treatment (acute treatment phase)
measure: Persistence: Average length of treatment
time frame: 6 months
description: Average length of treatment of each index drugs (allowing 14 day permissible gap) will be calculated.
-Switching, combination, augmentation, discontinuation will terminate the persistent period
measure: Discontinuation
time frame: 90 days
description: Percentage of patients discontinued each index drug within first 90 days of index treatment
measure: Adherence
time frame: 90 days
description: For each index drug, adherence will be measured as percentage of drug possessed (measured by medication possession ratio) within 90 days of index treatment
measure: Recurrence
time frame: 6 months
description: Percentage of patients experiencing recurrence (as measured by inpatient episode, emergency room visit, or suicide attempt) within 6 months of treatment
measure: Adverse outcomes
time frame: 6 months
description: Percentage of adverse events (as measured by GI bleeding, fractures, falls, intracranial hemorrhage, suicide attempt, self-harm, myocardial infarction, epilepsy/seizures, stroke, hyponatremia) within 6 months of treatment
measure: Drug utilization pattern in acute phase
time frame: 90 days
description: Percentage of patients on monotherapy, combination therapy, augmentation therapy during 90 days of treatment
measure: Drug utilization pattern in maintenance phase
time frame: 90 days
description: Precentage of patients on monotherapy, combination therapy, augmentation therapy during 90-180 days of treatment
arm group label: 1. Escitalopram Cohort
arm group label: 2. Paroxetine Cohort
arm group label: 3. Fluoxetine Cohort
arm group label: 4. Mirtazapine Cohort
arm group label: 5. Duloxetine Cohort
arm group label: 6. Sertraline Cohort
arm group label: 7. Venlafaxine Cohort
arm group label: 8. Tianeptine Cohort
arm group label: 9. Vortioxetine Cohort
arm group label: 10. Desvenlafaxine Cohort
arm group label: 11. Bupropion Cohort
intervention type: Drug
intervention name: Escitalopram
description: Treatment for depression
arm group label: 1. Escitalopram Cohort
intervention type: Drug
intervention name: Paroxetine
description: Treatment for depression
arm group label: 2. Paroxetine Cohort
intervention type: Drug
intervention name: Fluoxetine
description: Treatment for depression
arm group label: 3. Fluoxetine Cohort
intervention type: Drug
intervention name: Mirtazapine
description: Treatment for depression
arm group label: 4. Mirtazapine Cohort
intervention type: Drug
intervention name: Duloxetine
description: Treatment for depression
arm group label: 5. Duloxetine Cohort
intervention type: Drug
intervention name: Sertraline
description: Treatment for depression
arm group label: 6. Sertraline Cohort
intervention type: Drug
intervention name: Venlafaxine
description: Treatment for depression
arm group label: 7. Venlafaxine Cohort
intervention type: Drug
intervention name: Tianeptine
description: Treatment for depression
arm group label: 8. Tianeptine Cohort
intervention type: Drug
intervention name: Vortioxetine
description: Treatment for depression
arm group label: 9. Vortioxetine Cohort
intervention type: Drug
intervention name: Desvenlafaxine
description: Treatment for depression
arm group label: 10. Desvenlafaxine Cohort
intervention type: Drug
intervention name: Bupropion
description: Treatment for depression
arm group label: 11. Bupropion Cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: Korea, Republic of
url: https://pmiform.com/clinical-trial-info-request?StudyID=B2061147
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Depressive Disorder, Major
mesh term: Duloxetine Hydrochloride
mesh term: Vortioxetine
mesh term: Mirtazapine
mesh term: Bupropion
mesh term: Fluoxetine
mesh term: Paroxetine
mesh term: Venlafaxine Hydrochloride
mesh term: Sertraline
mesh term: Desvenlafaxine Succinate
mesh term: Tianeptine
mesh term: Escitalopram
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.