<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/NCT03270891</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00121185</org_study_id>
    <nct_id>NCT03270891</nct_id>
  </id_info>
  <brief_title>Pharmacogenomic Testing in Primary Care</brief_title>
  <official_title>Determining the Feasibility, Acceptability, and Preliminary Effectiveness of Pharmacogenomic Testing in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department&#xD;
      of family medicine (DFM) clinics at the University of Michigan (UM). Physicians practicing at&#xD;
      a UM DFM clinical site who are willing to utilize pharmacogenomic (PGx) test results to&#xD;
      manage antidepressant use will be enrolled. Patients of these DFM physicians who are adults&#xD;
      with a new prescription for a target antidepressant will also be enrolled.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department&#xD;
      of family medicine (DFM) clinics at the University of Michigan (UM). We will enroll&#xD;
      physicians practicing at a UM DFM clinical site who are willing to utilize PGx test results&#xD;
      in conjunction with treating patients prescribed certain antidepressants. We will also enroll&#xD;
      patients of these DFM physicians who are adults with a new prescription for an antidepressant&#xD;
      (within the past 4 weeks) including patients who have switched to a new antidepressant from&#xD;
      another antidepressant or have added on a new antidepressant to current antidepressant&#xD;
      therapy. Patients are excluded if taking an antidepressant for more than 4 weeks or if they&#xD;
      have had PGx testing in the past. Patients will be randomized to either an intervention or&#xD;
      control group. Patients in the intervention group will have PGx test results available soon&#xD;
      after enrollment while the control patients will have test results available 3 months after&#xD;
      the first visit. All patients will complete a baseline, 3-, and 6-month assessment; control&#xD;
      patients will have an additional 9-month assessment. Data to be collected include symptoms&#xD;
      and severity (PHQ-8, GAD7), functional health status (SF-12), PGx knowledge, work status&#xD;
      changes, demographic information, physician and emergency department visits, adverse effects,&#xD;
      and medication alterations and adherence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">May 6, 2022</completion_date>
  <primary_completion_date type="Actual">September 5, 2021</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Count of Participants Prescribed Antidepressant Medication</measure>
    <time_frame>Baseline, 3 months, 6 months, and 9 months</time_frame>
    <description>Count of participants who have been prescribed antidepressant medications which are not contraindicated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Symptom Severity - Patient Health Questionnaire (PHQ-8)</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Change in PHQ-8 scores. The PHQ-8 is an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Symptom Severity - General Anxiety Disorder - 7 (GAD 7)</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>The GAD-7 is a self-administered assessment for general anxiety disorder. The total score for the seven items ranges from 0 to 21. Higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Adherence to Refills and Medication Scale (ARMS) Scores</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Change in medication adherence: The Adherence to Refills and Medication was scored by summing together the 14 items after first reversing the final item to be consistent in direction with the others. Individuals were allowed to have up to 2 missing values present which were imputed with the mean of the remaining answered items, only a handful of individuals answered 13 of the 14 questions resulting in a single item within their scale being imputed across the time periods.&#xD;
The questionnaire has 14 items with each item being recorded on a four-point Likert scale. The total score ranges from 14-56 with the lower score indicating better adherence.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Acceptability of PGx Testing</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Acceptability of PGx testing in primary care among persons taking a target antidepressant and primary care physicians who care for them</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Antidepressants Causing Adverse Effects in Therapeutic Use</condition>
  <arm_group>
    <arm_group_label>Delayed intervention (control arm)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PGx Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PGx test</intervention_name>
    <description>A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
    <arm_group_label>Delayed intervention (control arm)</arm_group_label>
    <arm_group_label>PGx Test</arm_group_label>
    <other_name>Pharmacogenomic test</other_name>
    <other_name>Progenity Informed PGx test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Physician participants&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Be a practicing physician at a University of Michigan Department of Family Medicine&#xD;
             clinic&#xD;
&#xD;
          -  Be willing to use PGx test results for their patients enrolled in the study&#xD;
&#xD;
          -  Be willing to allow study staff to contact their patients&#xD;
&#xD;
          -  Self-report that they are willing to prescribe antidepressants&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        -Do not meet inclusion criteria&#xD;
&#xD;
        Patient Participants&#xD;
&#xD;
        Inclusion:&#xD;
&#xD;
          -  Be a patient of a participating physician&#xD;
&#xD;
          -  Have a new prescription for one of the following antidepressant medications:&#xD;
             citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Prozac Weekly,&#xD;
             Rapiflux, Sarafem, Selfemra), fluvoxamine (Luvox, Luvox CR), paroxetine (Paxil, Paxil&#xD;
             CR), sertraline (Zoloft), duloxetine (Cymbalta, Irenka), venlafaxine (Effexor),&#xD;
             venlafaxine XR (Effexor XR), nortriptyline (Aventyl, Pamelor), bupropion (Forfivo XL,&#xD;
             Wellbutrin, Wellbutrin SR, Wellbutrin XL), mirtazapine (Remeron, Remeron Soltab), or&#xD;
             vortioxetine (Trintellix)&#xD;
&#xD;
          -  Be willing to undergo PGx testing via single tube blood draw&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Do not speak English&#xD;
&#xD;
          -  Have previously undergone PGx testing&#xD;
&#xD;
          -  Are unable to provide their own consent to participate in the study&#xD;
&#xD;
          -  Have been taking the new antidepressant prescription for longer than 4 weeks (prior to&#xD;
             screening)&#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>Lorriane Buis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan Department of Family Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Manzor Mitrzyk B, Kadri R, Farris KB, Ellingrod VL, Klinkman MS, Ruffin Iv MT, Plegue MA, Buis LR. Using Pharmacogenomic Testing in Primary Care: Protocol for a Pilot Randomized Controlled Study. JMIR Res Protoc. 2019 Aug 19;8(8):e13848. doi: 10.2196/13848.</citation>
    <PMID>31429417</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <results_first_submitted>January 23, 2023</results_first_submitted>
  <results_first_submitted_qc>March 17, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 11, 2023</results_first_posted>
  <last_update_submitted>March 17, 2023</last_update_submitted>
  <last_update_submitted_qc>March 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Lorraine Buis</investigator_full_name>
    <investigator_title>Assistant Professor, Family Medicine Assistant Professor of Information, School of Information</investigator_title>
  </responsible_party>
  <keyword>Pharmacogenomics</keyword>
  <keyword>Primary care physicians</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03270891/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Delayed Intervention (Control Arm)</title>
          <description>Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment&#xD;
PGx test: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
        </group>
        <group group_id="P2">
          <title>PGx Test</title>
          <description>Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.&#xD;
PGx test: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
        </group>
        <group group_id="P3">
          <title>Physicians</title>
          <description>Physicians who practiced at 1 of the 6 UM Family Medicine clinics.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Intervention</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>For Physician Arm Only; Those Physicians Who Had Patients Who Participated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>For Physician arm only; those physicians who did not have patients who participated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>1 participant was withdrawn by the study staff and PI after baseline data was collected but before receiving the intervention.</population>
      <group_list>
        <group group_id="B1">
          <title>Delayed Intervention (Control Arm)</title>
          <description>Participants in this arm will have PGx test results made available to physicians 3 months after study enrollment&#xD;
PGx test: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
        </group>
        <group group_id="B2">
          <title>PGx Test</title>
          <description>Participants in this arm will have PGx test results made available to physicians as soon available after enrollment.&#xD;
PGx test: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
        </group>
        <group group_id="B3">
          <title>Physicians</title>
          <description>Physicians who practiced at 1 of the 6 UM Family Medicine clinics.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="24"/>
            <count group_id="B4" value="75"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Physician age is reported as a study specific outcome measure so that the total means are not mixed between participants and physicians.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.2" spread="13.2"/>
                    <measurement group_id="B2" value="42.0" spread="14.6"/>
                    <measurement group_id="B4" value="40.5" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Male</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <population>Protocol had no plans to collect marital status from physicians.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Not Married</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Married</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;4 yrs College</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bachelor's Degree</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Graduate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Unemployed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Employed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Income</title>
          <population>Protocol had no plans to collect income status from physicians.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;50k</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50k-99k</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100k+</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Children</title>
          <population>Protocol had no plans to collect number of children data from physicians.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>No Children</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Least One</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Status</title>
          <population>Protocol had no plans to collect smoking status from physicians.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Non-Smoker</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Smoker</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="25"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age of Physicians, Continuous</title>
          <population>This measure is for physician age only so it does not include patient participant data, in order to have the patient participant data mean totals remain accurate. Therefore patient participants are not analyzed here.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="24"/>
                    <count group_id="B4" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="41.83" spread="10.47"/>
                    <measurement group_id="B4" value="41.83" spread="10.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Count of Participants Prescribed Antidepressant Medication</title>
        <description>Count of participants who have been prescribed antidepressant medications which are not contraindicated</description>
        <time_frame>Baseline, 3 months, 6 months, and 9 months</time_frame>
        <population>Per protocol, only control arm patients were to have a 9 month assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Intervention (Control Arm)</title>
            <description>Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment&#xD;
PGx test: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
          </group>
          <group group_id="O2">
            <title>PGx Test</title>
            <description>Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.&#xD;
PGx test: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants Prescribed Antidepressant Medication</title>
          <description>Count of participants who have been prescribed antidepressant medications which are not contraindicated</description>
          <population>Per protocol, only control arm patients were to have a 9 month assessment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Symptom Severity - Patient Health Questionnaire (PHQ-8)</title>
        <description>Change in PHQ-8 scores. The PHQ-8 is an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>PHQ-8 data is unavailable for 8 participants in the control arm and 7 participants in the PGx Test arm because of missing data at 6 months or loss to follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Intervention (Control Arm)</title>
            <description>Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment&#xD;
PGx test: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
          </group>
          <group group_id="O2">
            <title>PGx Test</title>
            <description>Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.&#xD;
PGx test: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Symptom Severity - Patient Health Questionnaire (PHQ-8)</title>
          <description>Change in PHQ-8 scores. The PHQ-8 is an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.</description>
          <population>PHQ-8 data is unavailable for 8 participants in the control arm and 7 participants in the PGx Test arm because of missing data at 6 months or loss to follow-up.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" spread="4.4"/>
                    <measurement group_id="O2" value="8.6" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" spread="4.3"/>
                    <measurement group_id="O2" value="5.8" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Baseline and 6 month values</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Null hypothesis of equality.</non_inferiority_desc>
            <p_value>0.0115</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>baseline to 6 month comparison</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Null hypothesis of equality.</non_inferiority_desc>
            <p_value>0.027</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Symptom Severity - General Anxiety Disorder - 7 (GAD 7)</title>
        <description>The GAD-7 is a self-administered assessment for general anxiety disorder. The total score for the seven items ranges from 0 to 21. Higher values represent a worse outcome.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Because GAD-7 data is unavailable for 8 participants in the control arm and 7 participants in the PGx Test arm because of missing data at 6 months or loss to follow-up, the data is presented for those participants who had both data points so comparisons between the two time points are appropriate.</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Intervention (Control Arm)</title>
            <description>Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment&#xD;
PGx test: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
          </group>
          <group group_id="O2">
            <title>PGx Test</title>
            <description>Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.&#xD;
PGx test: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Symptom Severity - General Anxiety Disorder - 7 (GAD 7)</title>
          <description>The GAD-7 is a self-administered assessment for general anxiety disorder. The total score for the seven items ranges from 0 to 21. Higher values represent a worse outcome.</description>
          <population>Because GAD-7 data is unavailable for 8 participants in the control arm and 7 participants in the PGx Test arm because of missing data at 6 months or loss to follow-up, the data is presented for those participants who had both data points so comparisons between the two time points are appropriate.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" spread="6.2"/>
                    <measurement group_id="O2" value="6.9" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="5.0"/>
                    <measurement group_id="O2" value="5.2" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Baseline p value to six month</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Null hypothesis of equality.</non_inferiority_desc>
            <p_value>0.0327</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>baseline to 6 month comparison p value</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Null hypothesis of equality.</non_inferiority_desc>
            <p_value>0.2088</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Adherence to Refills and Medication Scale (ARMS) Scores</title>
        <description>Change in medication adherence: The Adherence to Refills and Medication was scored by summing together the 14 items after first reversing the final item to be consistent in direction with the others. Individuals were allowed to have up to 2 missing values present which were imputed with the mean of the remaining answered items, only a handful of individuals answered 13 of the 14 questions resulting in a single item within their scale being imputed across the time periods.&#xD;
The questionnaire has 14 items with each item being recorded on a four-point Likert scale. The total score ranges from 14-56 with the lower score indicating better adherence.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>ARMs data is unavailable for 10 participants in the control arm and 8 participants in the PGx Test arm because of missing data at 6 months or loss to follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Intervention (Control Arm)</title>
            <description>Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment&#xD;
PGx test: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
          </group>
          <group group_id="O2">
            <title>PGx Test</title>
            <description>Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.&#xD;
PGx test: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Adherence to Refills and Medication Scale (ARMS) Scores</title>
          <description>Change in medication adherence: The Adherence to Refills and Medication was scored by summing together the 14 items after first reversing the final item to be consistent in direction with the others. Individuals were allowed to have up to 2 missing values present which were imputed with the mean of the remaining answered items, only a handful of individuals answered 13 of the 14 questions resulting in a single item within their scale being imputed across the time periods.&#xD;
The questionnaire has 14 items with each item being recorded on a four-point Likert scale. The total score ranges from 14-56 with the lower score indicating better adherence.</description>
          <population>ARMs data is unavailable for 10 participants in the control arm and 8 participants in the PGx Test arm because of missing data at 6 months or loss to follow-up.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.1" spread="3.3"/>
                    <measurement group_id="O2" value="17.4" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" spread="2.5"/>
                    <measurement group_id="O2" value="16.6" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>baseline to 6 month comparison</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Null hypothesis of equality.</non_inferiority_desc>
            <p_value>0.947</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Acceptability of PGx Testing</title>
        <description>Acceptability of PGx testing in primary care among persons taking a target antidepressant and primary care physicians who care for them</description>
        <time_frame>Baseline and 6 months</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>six months</time_frame>
      <desc>Per protocol and because they received no intervention, no adverse event data was intended to be collected from physicians, so they are not presented here.</desc>
      <group_list>
        <group group_id="E1">
          <title>Delayed Intervention (Control Arm)</title>
          <description>Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment&#xD;
PGx test: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
        </group>
        <group group_id="E2">
          <title>PGx Test</title>
          <description>Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.&#xD;
PGx test: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Laurie Buis</name_or_title>
      <organization>University of Michigan</organization>
      <phone>734-998-5694</phone>
      <email>buisl@med.umich.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03270891
org study id: HUM00121185
nct id: NCT03270891
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department
      of family medicine (DFM) clinics at the University of Michigan (UM). Physicians practicing at
      a UM DFM clinical site who are willing to utilize pharmacogenomic (PGx) test results to
      manage antidepressant use will be enrolled. Patients of these DFM physicians who are adults
      with a new prescription for a target antidepressant will also be enrolled.
This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department
      of family medicine (DFM) clinics at the University of Michigan (UM). We will enroll
      physicians practicing at a UM DFM clinical site who are willing to utilize PGx test results
      in conjunction with treating patients prescribed certain antidepressants. We will also enroll
      patients of these DFM physicians who are adults with a new prescription for an antidepressant
      (within the past 4 weeks) including patients who have switched to a new antidepressant from
      another antidepressant or have added on a new antidepressant to current antidepressant
      therapy. Patients are excluded if taking an antidepressant for more than 4 weeks or if they
      have had PGx testing in the past. Patients will be randomized to either an intervention or
      control group. Patients in the intervention group will have PGx test results available soon
      after enrollment while the control patients will have test results available 3 months after
      the first visit. All patients will complete a baseline, 3-, and 6-month assessment; control
      patients will have an additional 9-month assessment. Data to be collected include symptoms
      and severity (PHQ-8, GAD7), functional health status (SF-12), PGx knowledge, work status
      changes, demographic information, physician and emergency department visits, adverse effects,
      and medication alterations and adherence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Count of Participants Prescribed Antidepressant Medication
time frame: Baseline, 3 months, 6 months, and 9 months
description: Count of participants who have been prescribed antidepressant medications which are not contraindicated
measure: Change in Symptom Severity - Patient Health Questionnaire (PHQ-8)
time frame: Baseline and 6 months
description: Change in PHQ-8 scores. The PHQ-8 is an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.
measure: Change in Symptom Severity - General Anxiety Disorder - 7 (GAD 7)
time frame: Baseline and 6 months
description: The GAD-7 is a self-administered assessment for general anxiety disorder. The total score for the seven items ranges from 0 to 21. Higher values represent a worse outcome.
measure: Change in Adherence to Refills and Medication Scale (ARMS) Scores
time frame: Baseline and 6 months
description: Change in medication adherence: The Adherence to Refills and Medication was scored by summing together the 14 items after first reversing the final item to be consistent in direction with the others. Individuals were allowed to have up to 2 missing values present which were imputed with the mean of the remaining answered items, only a handful of individuals answered 13 of the 14 questions resulting in a single item within their scale being imputed across the time periods.
The questionnaire has 14 items with each item being recorded on a four-point Likert scale. The total score ranges from 14-56 with the lower score indicating better adherence.
measure: Acceptability of PGx Testing
time frame: Baseline and 6 months
description: Acceptability of PGx testing in primary care among persons taking a target antidepressant and primary care physicians who care for them
arm group label: Delayed intervention (control arm)
arm group type: Active Comparator
description: Patients in this arm will have PGx test results made available to physicians 3 months after study enrollment
arm group label: PGx Test
arm group type: Experimental
description: Patients in this arm will have PGx test results made available to physicians as soon available after enrollment.
intervention type: Diagnostic Test
intervention name: PGx test
description: A laboratory developed genetic test that differentiates common and uncommon alleles in genes that have been previously identified as being involved in either the metabolism or response of drugs used in the treatment of depression and/or anxiety. The results are provided as a report that contains information related to the allele status of the patient's genes, translates this into a phenotype, and relates this phenotype to recommendation classes for drugs.
arm group label: Delayed intervention (control arm)
arm group label: PGx Test
other name: Pharmacogenomic test
other name: Progenity Informed PGx test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lorriane Buis, PhD
role: Principal Investigator
affiliation: University of Michigan Department of Family Medicine
facility: 
country: United States
citation: Manzor Mitrzyk B, Kadri R, Farris KB, Ellingrod VL, Klinkman MS, Ruffin Iv MT, Plegue MA, Buis LR. Using Pharmacogenomic Testing in Primary Care: Protocol for a Pilot Randomized Controlled Study. JMIR Res Protoc. 2019 Aug 19;8(8):e13848. doi: 10.2196/13848.
PMID: 31429417
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Lorraine Buis
investigator title: Assistant Professor, Family Medicine Assistant Professor of Information, School of Information
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 