<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/NCT01662817</url>
  </required_header>
  <id_info>
    <org_study_id>13487</org_study_id>
    <secondary_id>H6U-XM-S007</secondary_id>
    <nct_id>NCT01662817</nct_id>
  </id_info>
  <brief_title>Major Depressive Disorder (MDD)</brief_title>
  <official_title>Effectiveness of Physicians' Education, Implementation and Follow up of Current Recommendations Regarding Screening for Major Depressive Disorder in High Risk Patients on Improving the Under-Recognition Rates of Depression in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness of systematic screening for&#xD;
      depression in high-risk patient participants in everyday clinical practice. Systematic&#xD;
      screening for depression in high-risk patients is recommended to be included as a usual&#xD;
      practice but its effectiveness in this context remains controversial. In this study, 35&#xD;
      primary care physicians (PCPs) in Spain were assigned to intervention (receive one day&#xD;
      training in depression screening guidelines and use guidelines for six months) and 34 PCPs&#xD;
      were assigned to a control group (manage depression in the usual way for six months). There&#xD;
      were a total of 525 patient participants with MDD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">July 2010</completion_date>
  <primary_completion_date type="Actual">July 2010</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks</measure>
    <time_frame>24 Weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patient Participants with Under-Treatment of MDD Episodes at 24 Weeks</measure>
    <time_frame>24 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Primary Care Physician (PCP) Adherence to Intervention Questionnaire at 24 Weeks</measure>
    <time_frame>Baseline, 24 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in PCP Feasibility of Intervention Questionnaire at 24 Weeks</measure>
    <time_frame>Baseline, 24 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in PCP Acceptance of Intervention Questionnaire at 24 Weeks</measure>
    <time_frame>Baseline, 24 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Duration of Depressive Episodes in Patient Participants</measure>
    <time_frame>24 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impressions: Severity (CGI-S) Score in Patient Participants</measure>
    <time_frame>24 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sheehan Disability Scale (SDS) Score in Patient Participants</measure>
    <time_frame>24 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Duration of Sick Leave Due to Depression in Patient Participants</measure>
    <time_frame>24 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patient Participants with Sick Leave Due to Depression</measure>
    <time_frame>24 Weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">525</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <description>Intervention group primary care physician (PCP) receives one day training in depression screening guidelines and uses guidelines for six months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Control group PCP manages depression in the usual way for six months</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>PCP receives one day training in depression screening guidelines and uses guidelines for six months</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>PCP manages depression in the usual way for six months</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Care Physicians are given the intervention of education to utilize on screened and&#xD;
        consented patient participants under the PCP care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PCP Participants: PCPs informed of the study design and who agreed to be randomized to&#xD;
             the intervention or control group&#xD;
&#xD;
          -  Patient Participants: Aged 18 years or older who provide a written consent for the&#xD;
             collection and use of their clinical data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PCP Participants: If they already follow the recommendations on screening or were&#xD;
             planning to do so. If they will be absent from their practice for a significant period&#xD;
             during the study, or if they do not usually manage depression&#xD;
&#xD;
          -  PCP Participants: Those who were not able to understand the aims of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 8, 2012</last_update_submitted>
  <last_update_submitted_qc>August 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2012</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>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_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/NCT01662817
org study id: 13487
secondary id: H6U-XM-S007
nct id: NCT01662817
lead sponsor: 
has dmc: No
The purpose of this study is to assess the effectiveness of systematic screening for
      depression in high-risk patient participants in everyday clinical practice. Systematic
      screening for depression in high-risk patients is recommended to be included as a usual
      practice but its effectiveness in this context remains controversial. In this study, 35
      primary care physicians (PCPs) in Spain were assigned to intervention (receive one day
      training in depression screening guidelines and use guidelines for six months) and 34 PCPs
      were assigned to a control group (manage depression in the usual way for six months). There
      were a total of 525 patient participants with MDD.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks
time frame: 24 Weeks
measure: Percentage of Patient Participants with Under-Treatment of MDD Episodes at 24 Weeks
time frame: 24 Weeks
measure: Change from Baseline in Primary Care Physician (PCP) Adherence to Intervention Questionnaire at 24 Weeks
time frame: Baseline, 24 Weeks
measure: Change from Baseline in PCP Feasibility of Intervention Questionnaire at 24 Weeks
time frame: Baseline, 24 Weeks
measure: Change from Baseline in PCP Acceptance of Intervention Questionnaire at 24 Weeks
time frame: Baseline, 24 Weeks
measure: Mean Duration of Depressive Episodes in Patient Participants
time frame: 24 Weeks
measure: Clinical Global Impressions: Severity (CGI-S) Score in Patient Participants
time frame: 24 Weeks
measure: Sheehan Disability Scale (SDS) Score in Patient Participants
time frame: 24 Weeks
measure: Mean Duration of Sick Leave Due to Depression in Patient Participants
time frame: 24 Weeks
measure: Percentage of Patient Participants with Sick Leave Due to Depression
time frame: 24 Weeks
arm group label: Intervention
description: Intervention group primary care physician (PCP) receives one day training in depression screening guidelines and uses guidelines for six months
arm group label: Control
description: Control group PCP manages depression in the usual way for six months
intervention type: Behavioral
intervention name: Intervention
description: PCP receives one day training in depression screening guidelines and uses guidelines for six months
arm group label: Intervention
intervention type: Behavioral
intervention name: Control
description: PCP manages depression in the usual way for six months
arm group label: Control
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major