xml: <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/NCT06036160</url>
    </required_header>
    <id_info>
      <org_study_id>202201</org_study_id>
      <nct_id>NCT06036160</nct_id>
    </id_info>
    <brief_title>Feasibility of Integrated Care of Depression in Primary Care Pathways</brief_title>
    <acronym>ESPRI-PSY</acronym>
    <official_title>Evaluation de Soins Primaires Intégrés en Psychiatrie</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Association De La Msp Pasteur</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Association De La Msp Pasteur</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>
        This protocol is a feasibility study of an integrated primary care pathway for patients&#xD;
        suffering from difficult-to-treat depression. 50 patients will be recruited and followed for&#xD;
        two years.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of patients completing the study per-protocol</measure>
      <time_frame>3 years</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Depressive Disorder</condition>
    <arm_group>
      <arm_group_label>Integrated care</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Integrated care</intervention_name>
      <description>Psychiatric follow-up, cognitive behavioral therapy, physical exercise, psychoeducation</description>
      <arm_group_label>Integrated care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age 18-65 years&#xD;
  &#xD;
            -  Good understanding of french language&#xD;
  &#xD;
            -  Major depressive disorder based on DSM-V criteria&#xD;
  &#xD;
            -  MADRS &gt; 19&#xD;
  &#xD;
            -  FAilure of two antidepressants during 6wks at standard minimal dose&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy or lactating&#xD;
  &#xD;
            -  People under tutelage&#xD;
  &#xD;
            -  bipolar disorder&#xD;
  &#xD;
            -  no health insurance&#xD;
  &#xD;
            -  neurological disorders&#xD;
  &#xD;
            -  contra-indication to physical activity&#xD;
  &#xD;
            -  high suicidal risk&#xD;
  &#xD;
            -  first degree history of bipolar disorder, schizophrenia, autism spectrum disorder&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036160
  org study id: 202201
  nct id: NCT06036160
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This protocol is a feasibility study of an integrated primary care pathway for patients
        suffering from difficult-to-treat depression. 50 patients will be recruited and followed for
        two years.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Percentage of patients completing the study per-protocol
  time frame: 3 years
  arm group label: Integrated care
  arm group type: Experimental
  intervention type: Other
  intervention name: Integrated care
  description: Psychiatric follow-up, cognitive behavioral therapy, physical exercise, psychoeducation
  arm group label: Integrated care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Depressive Disorder
  sharing ipd: No