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/NCT05976347</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00096491</org_study_id>
      <secondary_id>MSKRSH040123</secondary_id>
      <nct_id>NCT05976347</nct_id>
    </id_info>
    <brief_title>Identifying and Treating Depression in the Orthopaedic Trauma Population</brief_title>
    <official_title>Identifying and Treating Depression in the Orthopaedic Trauma Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wake Forest University Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wake Forest University Health Sciences</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 goal of this trial is to pilot a way for orthopaedic surgeons to safely screen for&#xD;
        depression and provide treatment for depression with medication. The main questions it aims&#xD;
        to answer are:&#xD;
  &#xD;
          1. What are the outcomes of patients who screen positive for depressive symptoms and are&#xD;
             prescribed either an Selective serotonin reuptake inhibitors (SSRI) or serotonin and&#xD;
             norepinephrine reuptake inhibitors (SNRI).&#xD;
  &#xD;
          2. What are the outcomes of patients who screen positive for depressive symptoms and choose&#xD;
             not to pursue treatment with medication?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Depression is common among orthopaedic trauma patients and associated with worsened outcomes&#xD;
        including pain, opioid consumption, patient-reported outcomes ,complications, and length of&#xD;
        stay. Addressing depression, therefore, should lead to improved outcomes. Orthopaedic&#xD;
        surgeons may believe treating depression is outside their scope or that they lack tools to&#xD;
        address depressive symptoms. In fact, only 45% of surgeons report they are likely to screen&#xD;
        patients, and only 27% are likely to refer patients for psychological treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Patients will be randomized to receive either an Selective serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI), and patients who are not interested in taking medication for their symptoms will be enrolled in an observational arm.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Depressive Symptom Scores</measure>
      <time_frame>Baseline</time_frame>
      <description>Improvement in depressive symptoms, indication by either remission (PHQ-9 score &lt;5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depressive Symptom Scores</measure>
      <time_frame>Month 3</time_frame>
      <description>Improvement in depressive symptoms, indication by either remission (PHQ-9 score &lt;5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depressive Symptom Scores</measure>
      <time_frame>Month 6</time_frame>
      <description>Improvement in depressive symptoms, indication by either remission (PHQ-9 score &lt;5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depressive Symptom Scores</measure>
      <time_frame>Month 9</time_frame>
      <description>Improvement in depressive symptoms, indication by either remission (PHQ-9 score &lt;5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depressive Symptom Scores</measure>
      <time_frame>Year 1</time_frame>
      <description>Improvement in depressive symptoms, indication by either remission (PHQ-9 score &lt;5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adherence to Treatment Percentage</measure>
      <time_frame>Months 3, 6, and 12</time_frame>
      <description>Adherence to treatment and side effects or adverse events associated with the medications will be collected using patient logs, study visit questionnaires, and the medical record (i.e., number of prescriptions filled).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Utilization of non-pharmaceutical tools and resources Percentage</measure>
      <time_frame>Months 3, 6, and 12</time_frame>
      <description>Engagement with behavioral health resources will be collected using patient logs, study visit questionnaires, and the medical record (i.e., number of visits with Behavioral Health).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcome Measures - PROMIS-29 Scores</measure>
      <time_frame>Months 3, 6, and 12</time_frame>
      <description>The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean a higher level of disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcome Measures - Work Productivity and Activity Impairment Questionnaire Scores</measure>
      <time_frame>Months 3, 6, and 12</time_frame>
      <description>The Work Productivity and Activity Impairment questionnaire measures how work productivity and activities are impaired by a specific health condition or disease. Scores are expressed as a percentage of impairment/productivity loss, a high score indicates greater impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcome Measures - Brief Pain Inventory Scores</measure>
      <time_frame>Months 3, 6, and 12</time_frame>
      <description>Assesses the severity of pain and the impact of pain on daily functions. Assesses the severity of and impact of pain on daily function. Patients are asked to rate their current symptoms, average experiences of pain, and the minimum and maximum intensities of their symptoms on scales that range from 1-10. A total pain severity score can be found by averaging these items or a single items can be treated as the primary outcome. Higher scores indicate greater severity and more interference.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healthcare Utilization - The number of hospitalizations and ED visits</measure>
      <time_frame>Months 3, 6, and 12</time_frame>
      <description>The number of hospitalizations and ED visits</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcome Measures: Patient Health Questionnaire 9 (PHQ-9)</measure>
      <time_frame>Months 3, 6, and 12</time_frame>
      <description>A PHQ-9 score total of 0-4 points equals &quot;normal&quot; or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression. The higher the score, the more symptoms of depression experienced, and the more severe the depression is.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcome Measures - Veterans RAND 12 Item Health Survey (VR-12)</measure>
      <time_frame>Months 3, 6, and 12</time_frame>
      <description>Measures health related quality of life across 7 domains. The answers are summarized into two scores - a Physical Component Score and a Mental Component Score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Qualitative Interview Information</measure>
      <time_frame>One time between 6-12 months</time_frame>
      <description>Patients in the observational arm will participate in semi-structured interviews. Interviews will be recorded and transcribed verbatim within one week. Field notes will be written within one week of each interview, and the interview guide will be revised as appropriate.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>Selective serotonin reuptake inhibitors (SSRI)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Fluoxetine, 20mg once daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>serotonin and norepinephrine reuptake inhibitors (SNRI)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Duloxetine, 30mg once daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Observational</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Referral to behavioral health per standard practice and provision of resources for strategices to address depressive symptoms.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fluoxetine 20 MG</intervention_name>
      <description>Fluoxetine 20 mg once daily</description>
      <arm_group_label>Selective serotonin reuptake inhibitors (SSRI)</arm_group_label>
      <other_name>Prozac Weekly, Sarafem, Prozac</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Duloxetine 30 MG</intervention_name>
      <description>Duloxetine 30 mg once daily</description>
      <arm_group_label>serotonin and norepinephrine reuptake inhibitors (SNRI)</arm_group_label>
      <other_name>Irenka and Cymbalta</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Observation</intervention_name>
      <description>Referral to behavioral health and resources for addressing depressive symptoms</description>
      <arm_group_label>Observational</arm_group_label>
      <other_name>Referral to behavioral health and resources</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients presenting to an Orthopaedic trauma clinic for the first time following&#xD;
               operative extremity fracture or any pelvis fracture&#xD;
  &#xD;
            -  A score of greater than or equal to 5 on the Patient Health Questionnaire-9 (PHQ-9) at&#xD;
               first post- operative visit&#xD;
  &#xD;
            -  Age 18 or older&#xD;
  &#xD;
            -  Speak English or Spanish&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently taking medication to treat depression&#xD;
  &#xD;
            -  Contraindication/allergy to one of the study medications&#xD;
  &#xD;
            -  Bipolar disorder of psychotic disorder&#xD;
  &#xD;
            -  Endorse suicidal ideation&#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>Meghan K Wally, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wake Forest University Health Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Erica Grochowski, MPH</last_name>
      <phone>704-403-4980</phone>
      <email>Erica.Grochowski@atriumhealth.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Wake Forest University Health Sciences</name>
        <address>
          <city>Winston-Salem</city>
          <state>North Carolina</state>
          <zip>27157</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Erica Grochowski, MPH</last_name>
        <phone>704-403-4980</phone>
        <email>Erica.Grochowski@atriumhealth.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 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>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>Duloxetine Hydrochloride</mesh_term>
      <mesh_term>Fluoxetine</mesh_term>
    </intervention_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/NCT05976347
  org study id: IRB00096491
  secondary id: MSKRSH040123
  nct id: NCT05976347
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The goal of this trial is to pilot a way for orthopaedic surgeons to safely screen for
        depression and provide treatment for depression with medication. The main questions it aims
        to answer are:
  
          1. What are the outcomes of patients who screen positive for depressive symptoms and are
             prescribed either an Selective serotonin reuptake inhibitors (SSRI) or serotonin and
             norepinephrine reuptake inhibitors (SNRI).
  
          2. What are the outcomes of patients who screen positive for depressive symptoms and choose
             not to pursue treatment with medication?
  Depression is common among orthopaedic trauma patients and associated with worsened outcomes
        including pain, opioid consumption, patient-reported outcomes ,complications, and length of
        stay. Addressing depression, therefore, should lead to improved outcomes. Orthopaedic
        surgeons may believe treating depression is outside their scope or that they lack tools to
        address depressive symptoms. In fact, only 45% of surgeons report they are likely to screen
        patients, and only 27% are likely to refer patients for psychological treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be randomized to receive either an Selective serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI), and patients who are not interested in taking medication for their symptoms will be enrolled in an observational arm.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Depressive Symptom Scores
  time frame: Baseline
  description: Improvement in depressive symptoms, indication by either remission (PHQ-9 score <5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.
  measure: Depressive Symptom Scores
  time frame: Month 3
  description: Improvement in depressive symptoms, indication by either remission (PHQ-9 score <5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.
  measure: Depressive Symptom Scores
  time frame: Month 6
  description: Improvement in depressive symptoms, indication by either remission (PHQ-9 score <5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.
  measure: Depressive Symptom Scores
  time frame: Month 9
  description: Improvement in depressive symptoms, indication by either remission (PHQ-9 score <5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.
  measure: Depressive Symptom Scores
  time frame: Year 1
  description: Improvement in depressive symptoms, indication by either remission (PHQ-9 score <5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.
  measure: Adherence to Treatment Percentage
  time frame: Months 3, 6, and 12
  description: Adherence to treatment and side effects or adverse events associated with the medications will be collected using patient logs, study visit questionnaires, and the medical record (i.e., number of prescriptions filled).
  measure: Utilization of non-pharmaceutical tools and resources Percentage
  time frame: Months 3, 6, and 12
  description: Engagement with behavioral health resources will be collected using patient logs, study visit questionnaires, and the medical record (i.e., number of visits with Behavioral Health).
  measure: Patient Reported Outcome Measures - PROMIS-29 Scores
  time frame: Months 3, 6, and 12
  description: The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean a higher level of disability.
  measure: Patient Reported Outcome Measures - Work Productivity and Activity Impairment Questionnaire Scores
  time frame: Months 3, 6, and 12
  description: The Work Productivity and Activity Impairment questionnaire measures how work productivity and activities are impaired by a specific health condition or disease. Scores are expressed as a percentage of impairment/productivity loss, a high score indicates greater impairment.
  measure: Patient Reported Outcome Measures - Brief Pain Inventory Scores
  time frame: Months 3, 6, and 12
  description: Assesses the severity of pain and the impact of pain on daily functions. Assesses the severity of and impact of pain on daily function. Patients are asked to rate their current symptoms, average experiences of pain, and the minimum and maximum intensities of their symptoms on scales that range from 1-10. A total pain severity score can be found by averaging these items or a single items can be treated as the primary outcome. Higher scores indicate greater severity and more interference.
  measure: Healthcare Utilization - The number of hospitalizations and ED visits
  time frame: Months 3, 6, and 12
  description: The number of hospitalizations and ED visits
  measure: Patient Reported Outcome Measures: Patient Health Questionnaire 9 (PHQ-9)
  time frame: Months 3, 6, and 12
  description: A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression. The higher the score, the more symptoms of depression experienced, and the more severe the depression is.
  measure: Patient Reported Outcome Measures - Veterans RAND 12 Item Health Survey (VR-12)
  time frame: Months 3, 6, and 12
  description: Measures health related quality of life across 7 domains. The answers are summarized into two scores - a Physical Component Score and a Mental Component Score.
  measure: Qualitative Interview Information
  time frame: One time between 6-12 months
  description: Patients in the observational arm will participate in semi-structured interviews. Interviews will be recorded and transcribed verbatim within one week. Field notes will be written within one week of each interview, and the interview guide will be revised as appropriate.
  arm group label: Selective serotonin reuptake inhibitors (SSRI)
  arm group type: Experimental
  description: Fluoxetine, 20mg once daily
  arm group label: serotonin and norepinephrine reuptake inhibitors (SNRI)
  arm group type: Experimental
  description: Duloxetine, 30mg once daily
  arm group label: Observational
  arm group type: Other
  description: Referral to behavioral health per standard practice and provision of resources for strategices to address depressive symptoms.
  intervention type: Drug
  intervention name: Fluoxetine 20 MG
  description: Fluoxetine 20 mg once daily
  arm group label: Selective serotonin reuptake inhibitors (SSRI)
  other name: Prozac Weekly, Sarafem, Prozac
  intervention type: Drug
  intervention name: Duloxetine 30 MG
  description: Duloxetine 30 mg once daily
  arm group label: serotonin and norepinephrine reuptake inhibitors (SNRI)
  other name: Irenka and Cymbalta
  intervention type: Other
  intervention name: Observation
  description: Referral to behavioral health and resources for addressing depressive symptoms
  arm group label: Observational
  other name: Referral to behavioral health and resources
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Meghan K Wally, PhD
  role: Principal Investigator
  affiliation: Wake Forest University Health Sciences
  last name: Erica Grochowski, MPH
  phone: 704-403-4980
  email: Erica.Grochowski@atriumhealth.org
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Duloxetine Hydrochloride
  mesh term: Fluoxetine
  sharing ipd: No