<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/NCT02245373</url>
  </required_header>
  <id_info>
    <org_study_id>Infap</org_study_id>
    <nct_id>NCT02245373</nct_id>
  </id_info>
  <brief_title>Cost-effectiveness of a Non-Pharmacological Treatment (Active Monitoring) vs. a Pharmacological Treatment for Major Depression in Primary Care.</brief_title>
  <official_title>Cost-effectiveness of a Non-Pharmacological Treatment (Active Monitoring) vs. a Pharmacological Treatment for Major Depression in Primary Care. INFAP Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Sant Joan de Déu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundació Sant Joan de Déu</source>
  <brief_summary>
    <textblock>
      Major Depression (MD) is highly prevalent and has associated a high burden and economic&#xD;
      costs. Mild levels of MD could be treated without antidepressants at Primary Care (PC).&#xD;
&#xD;
      Main objectives: 1) To calculate the cost-effectiveness of active monitoring (recommended by&#xD;
      NICE) vs pharmacological antidepressant treatment to treat mild MD at PC level.&#xD;
&#xD;
      Methods: 300 patients (≥18 years) with MD (diagnosed by the GP) will be recruited at the PC&#xD;
      center. Depending on the level of symptoms, the GP will choose between: A) Active Monitoring&#xD;
      (n=150) and B) pharmacological treatment (n=150).&#xD;
&#xD;
      Patients will be followed-up for one year and data will be collected at baseline, 6 and 12&#xD;
      months. Severity will be assessed by Patient Health Questionnaire (PHQ-9), quality of life&#xD;
      with the EuroQoL-5D (5 health dimensions), and the use of services with an adapted version of&#xD;
      the Client Service Receipt Inventory (including lost productivity).&#xD;
&#xD;
      Cost-effectiveness and cost-utility analysis will be calculated and 5000 bootstrapping&#xD;
      replications will be conducted to asses uncertainty. Cost-acceptability curves will be done&#xD;
      using two perspectives: the National Health Service perspective and the Societal perspective.&#xD;
&#xD;
      The Propensity Score technique will minimize the absence of randomization, matching cases&#xD;
      from both treatment options.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2013</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Compare the cost-effectiveness of active monitoring (standard treatment without antidepressants) vs antidepressants in mild major depression taking into account the severity and disability in Primary Care. The changes at Time Frame will be assessed.</measure>
    <time_frame>At base Line, 6 months and 12 months.</time_frame>
    <description>Measures: Severity of Depression (PHQ-9), Quality of life (EuroQol) and the use of services (Client Service Receipt Inventory, CSRI).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>1.Quality of life of patients with major depression who initiate treatment in Primary Care.</measure>
    <time_frame>At base line, 6 months and 12 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2. Cost-utility of an antidepressant vs no treatment in mild Depression in Primary.</measure>
    <time_frame>At base line, 6 months and 12 months.</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">263</enrollment>
  <condition>Mild to Moderate Depression.</condition>
  <arm_group>
    <arm_group_label>Antidepressants</arm_group_label>
    <description>Naturalistic assignment: Patients whose physician decides to indicate antidepressants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Monitoring</arm_group_label>
    <description>Naturalistic assignment: Patients whose physician considers starting an Active Monitoring intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antidepressants</intervention_name>
    <arm_group_label>Antidepressants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Active Monitoring</intervention_name>
    <arm_group_label>Active Monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care patients who suffer from major depression.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients whose GP considers to have major depression. The indication of&#xD;
             pharmacological or non-pharmacological treatment will be based strictly on the&#xD;
             clinical judgment of the physician.&#xD;
&#xD;
          2. Adults (≥18 years)&#xD;
&#xD;
          3. Informed consent signed by the physician and the patient to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of antidepressant drugs during the previous 60 days to inclusion date.&#xD;
&#xD;
          2. Alcohol or other toxic abuse.&#xD;
&#xD;
          3. Psychosis or bipolar disorder identified in the psychiatric interview&#xD;
&#xD;
          4. Use in the last 6 months of antipsychotic drugs, lithium or antiepileptic&#xD;
&#xD;
          5. Health status (pregnancy) and / or disease and / or treatments that contraindicate the&#xD;
             use of antidepressant drugs.&#xD;
&#xD;
          6. Terminal illness.&#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>Antoni Serrano, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació Sant Joan de Déu</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 17, 2014</last_update_submitted>
  <last_update_submitted_qc>September 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Primary Care</keyword>
  <keyword>Cost-effectiveness</keyword>
  <keyword>Pharmacological treatment</keyword>
  <keyword>Watchful-waiting or Active Monitoring.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Antidepressive Agents</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02245373
org study id: Infap
nct id: NCT02245373
lead sponsor: 
Major Depression (MD) is highly prevalent and has associated a high burden and economic
      costs. Mild levels of MD could be treated without antidepressants at Primary Care (PC).

      Main objectives: 1) To calculate the cost-effectiveness of active monitoring (recommended by
      NICE) vs pharmacological antidepressant treatment to treat mild MD at PC level.

      Methods: 300 patients (≥18 years) with MD (diagnosed by the GP) will be recruited at the PC
      center. Depending on the level of symptoms, the GP will choose between: A) Active Monitoring
      (n=150) and B) pharmacological treatment (n=150).

      Patients will be followed-up for one year and data will be collected at baseline, 6 and 12
      months. Severity will be assessed by Patient Health Questionnaire (PHQ-9), quality of life
      with the EuroQoL-5D (5 health dimensions), and the use of services with an adapted version of
      the Client Service Receipt Inventory (including lost productivity).

      Cost-effectiveness and cost-utility analysis will be calculated and 5000 bootstrapping
      replications will be conducted to asses uncertainty. Cost-acceptability curves will be done
      using two perspectives: the National Health Service perspective and the Societal perspective.

      The Propensity Score technique will minimize the absence of randomization, matching cases
      from both treatment options.
observational model: Case-Control
time perspective: Prospective
measure: Compare the cost-effectiveness of active monitoring (standard treatment without antidepressants) vs antidepressants in mild major depression taking into account the severity and disability in Primary Care. The changes at Time Frame will be assessed.
time frame: At base Line, 6 months and 12 months.
description: Measures: Severity of Depression (PHQ-9), Quality of life (EuroQol) and the use of services (Client Service Receipt Inventory, CSRI).
measure: 1.Quality of life of patients with major depression who initiate treatment in Primary Care.
time frame: At base line, 6 months and 12 months.
measure: 2. Cost-utility of an antidepressant vs no treatment in mild Depression in Primary.
time frame: At base line, 6 months and 12 months.
arm group label: Antidepressants
description: Naturalistic assignment: Patients whose physician decides to indicate antidepressants.
arm group label: Active Monitoring
description: Naturalistic assignment: Patients whose physician considers starting an Active Monitoring intervention.
intervention type: Drug
intervention name: Antidepressants
arm group label: Antidepressants
intervention type: Other
intervention name: Active Monitoring
arm group label: Active Monitoring
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antoni Serrano, PhD
role: Principal Investigator
affiliation: Fundació Sant Joan de Déu
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Antidepressive Agents