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/NCT05966155</url>
    </required_header>
    <id_info>
      <org_study_id>PRO00104948_C</org_study_id>
      <secondary_id>U01HG010225</secondary_id>
      <nct_id>NCT05966155</nct_id>
    </id_info>
    <brief_title>A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Depression Trial)</brief_title>
    <acronym>ADOPT PGx</acronym>
    <official_title>A Depression and Opioid Pragmatic Trial in Pharmacogenetics</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Human Genome Research Institute (NHGRI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Duke University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is comprised of three separate pharmacogenetic trials grouped into a single&#xD;
        protocol due to similarities in the intervention, the hypotheses, and the trial design. The&#xD;
        three trials are the Acute Pain Trial, the Chronic Pain Trial, and the Depression Trial.&#xD;
        Participants can enroll in only one of the three trials. All three trials were registered on&#xD;
        ClinicalTrials.gov under NCT04445792. In July 2023 each of the three treatment trials was&#xD;
        registered under a separate NCT# and NCT04445792 was converted to a screening record per&#xD;
        recent guidance on master protocol research programs (MPRPs). This record is specific to the&#xD;
        Depression Trial within the ADOPT-PGx protocol.&#xD;
  &#xD;
        The Depression Trial is a prospective, multicenter, two arm randomized pragmatic trial.&#xD;
        Participants meeting eligibility criteria will be randomly assigned to either immediate&#xD;
        pharmacogenetic testing and genotype-guided anti-depressant therapy (Intervention arm) or&#xD;
        standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators&#xD;
        will test the hypothesis that pharmacogenetic testing and genotype-guided anti-depressant&#xD;
        therapy will reduce depression symptoms in participants who's body processes some&#xD;
        anti-depressants faster or slower than normal.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pain and depression are conditions that impact substantial proportions of the US population.&#xD;
        Finding safe and effective drug therapies for both conditions is challenging. In the case of&#xD;
        treatment for acute and chronic pain, the challenge is finding effective therapy while&#xD;
        minimizing adverse effects or opioid addiction (and the ensuing consequences). For&#xD;
        depression, there are few clinically relevant predictors of successful treatment leading to&#xD;
        multiple trials of inadequate therapy for some patients. Both opioid and antidepressant&#xD;
        prescriptions can be guided by pharmacogenetics (PGx) data based on existing guidelines from&#xD;
        the Clinical Pharmacogenetics Implementation Consortium (CPIC).&#xD;
  &#xD;
        This study is designed to evaluate the impact of pharmacogenetic testing and genotype-guided&#xD;
        pain or anti-depressant therapy on pain control or depression symptoms in a pragmatic&#xD;
        setting.&#xD;
  &#xD;
        The rationale for examining a genotype-guided approach to acute and chronic pain management&#xD;
        is based on the importance of CYP2D6 for the bioactivation of tramadol, codeine, and&#xD;
        hydrocodone and data from a pilot study supporting improved pain control in intermediate and&#xD;
        poor CYP2D6 metabolizers in the genotype-guided arm who are taking these drugs at baseline.&#xD;
        Similarly, the rationale for examining a genotype-guided approach to depression medication&#xD;
        therapy is based on the demonstrated role of CYP2D6 in the bio inactivation and CYP2C19&#xD;
        oxidation of select, commonly used SSRIs. Secondly, data from industry sponsored trials&#xD;
        support the hypothesis of improved depression symptom control in a genotype-guided arm.&#xD;
  &#xD;
        Study objectives:&#xD;
  &#xD;
        Determine if genotype-guided dosing or selection of antidepressants among participants with&#xD;
        at least 3 months of depressive symptoms who require new or revised antidepressant therapy&#xD;
        leads to improved control of depression, compared to usual care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2021</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</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>
      <intervention_model_description>Immediate vs. delayed pharmacogenetic testing and genotype-guided pain or depression therapy</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>3 Month Depression Symptom Control Change from Baseline</measure>
      <time_frame>Baseline and 3 months</time_frame>
      <description>Depression symptom control, defined as change in PROMIS depression T-scores from baseline to 3-months in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>3 Month Change in PHQ of Depression Symptomatology Change from Baseline Scores</measure>
      <time_frame>baseline and 3 months</time_frame>
      <description>Change in PHQ-8 scores between baseline and 3 months in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers. Achieve 50% reduction in scores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3 Month Medication Side Effect Burden Change from Baseline</measure>
      <time_frame>3 months</time_frame>
      <description>Side effect burden is defined as the number of side effects experienced from a specified list of possible side effects, weighted by the severity of each side effect in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3 Month Medication Adherence Change from Baseline</measure>
      <time_frame>3 months</time_frame>
      <description>Medication adherence score derived from the Voils Medication Adherence survey in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6 Month Depression Remission Change from Baseline</measure>
      <time_frame>6 months</time_frame>
      <description>Remission is defined as whether or not the summed raw responses to the PROMIS emotional distress depression survey is ≤ 16, corresponding to a participant respond &quot;rarely&quot; or &quot;never&quot; to most or all questions.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1512</enrollment>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>Depression - Immediate PGx Testing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Depression - Delayed PGx Testing</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pharmacogenetic testing</intervention_name>
      <description>Genetic testing of CYP2D6 and CYP2C19</description>
      <arm_group_label>Depression - Delayed PGx Testing</arm_group_label>
      <arm_group_label>Depression - Immediate PGx Testing</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Clinical decisions support</intervention_name>
      <description>Prescribing recommendations to the provider based on the pharmacogenetic testing results</description>
      <arm_group_label>Depression - Immediate PGx Testing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Depression Trial&#xD;
  &#xD;
            -  Age ≥ 8 years&#xD;
  &#xD;
            -  English speaking or Spanish speaking&#xD;
  &#xD;
            -  Patients followed at psychiatry clinics or primary care clinics at an enrolling site&#xD;
               (such as, but not limited to, Internal Medicine, Family Medicine, or Pediatrics)&#xD;
  &#xD;
            -  Documentation of depression and/or provider report of depression&#xD;
  &#xD;
            -  Evidence of depressive symptoms for at least 3 months based on patient interview or&#xD;
               documentation in electronic health records&#xD;
  &#xD;
            -  Recent initiation of SSRI therapy, recent revised SSRI therapy, or anticipated need&#xD;
               for revised or new SSRI therapy per health care provider&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
          Trial-wide:&#xD;
  &#xD;
            -  Life expectancy less than 12 months&#xD;
  &#xD;
            -  Are too cognitively impaired to provide informed consent and/or complete study&#xD;
               protocol&#xD;
  &#xD;
            -  Are institutionalized or too ill to participate (i.e. mental or nursing home facility&#xD;
               or incarcerated)&#xD;
  &#xD;
            -  Have a history of allogeneic stem cell transplant or liver transplant&#xD;
  &#xD;
            -  People with prior clinical pharmacogenetic test results for genes relevant for the&#xD;
               study in which they will enroll (CYP2D6 for the pain studies and CYP2D6 or CYP2C19 for&#xD;
               depression) or already enrolled in an ADOPT PGx trial&#xD;
  &#xD;
          Depression Trial&#xD;
  &#xD;
            -  Plan to move out of the area within 6 months of enrollment&#xD;
  &#xD;
            -  Have active psychosis or diagnosed psychotic disorders (schizophrenia, schizoaffective&#xD;
               disorder, delusional disorder, psychotic depression, substance induced psychosis,&#xD;
               schizophreniform disorder)&#xD;
  &#xD;
            -  Have dementia or other neurocognitive disorders due to any cause, such as Alzheimer's&#xD;
               disease, vascular/subcortical, lewy body disease, frontotemporal lobar degeneration&#xD;
  &#xD;
            -  Have cognitive developmental delay and/or cognitive disability, including autism&#xD;
               spectrum disorders (Note: ADHD is not an exclusion criteria)&#xD;
  &#xD;
            -  Has a seizure disorder&#xD;
  &#xD;
            -  Have bipolar disorder&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hrishikesh Chakraborty</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kady-Ann Steen-Burrell</last_name>
      <phone>919-530-9711</phone>
      <email>kady.ann.steen.burrell@duke.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nemours Children's Health System</name>
        <address>
          <city>Wilmington</city>
          <state>Delaware</state>
          <zip>19803</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kathryn Blake, PharmD</last_name>
        <phone>904-697-3600</phone>
        <phone_ext>3806</phone_ext>
        <email>kathryn.blake@nemours.org</email>
      </contact>
      <investigator>
        <last_name>Kathryn Blake, Pharm D</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Florida - Gainesville</name>
        <address>
          <city>Gainesville</city>
          <state>Florida</state>
          <zip>32610</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Larisa Cavallari, MD</last_name>
        <phone>352-273-8245</phone>
        <email>lcavallari@cop.ufl.edu</email>
      </contact>
      <investigator>
        <last_name>Larisa Cavallari, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nemours Children's Health System</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32207</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kathryn Blake, PharmD</last_name>
        <phone>904-697-3600</phone>
        <phone_ext>3806</phone_ext>
        <email>kathryn.blake@nemours.org</email>
      </contact>
      <investigator>
        <last_name>Kathryn Blake, PharmD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Florida - Jacksonville</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32209</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Larisa Cavallari, MD</last_name>
        <phone>352-273-8245</phone>
        <email>lcavallari@cop.ufl.edu</email>
      </contact>
      <investigator>
        <last_name>Larisa Cavallari, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nemours Children's Health System</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32827</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kathryn Blake, PharmD</last_name>
        <phone>904-697-3600</phone>
        <phone_ext>3806</phone_ext>
        <email>kathryn.blake@nemours.org</email>
      </contact>
      <investigator>
        <last_name>Kathryn Blake, PharmD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Eskenazi Health</name>
        <address>
          <city>Indianapolis</city>
          <state>Indiana</state>
          <zip>46202</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Todd Skaar, MD</last_name>
        <phone>317-460-9748</phone>
        <email>tskaar@iu.edu</email>
      </contact>
      <investigator>
        <last_name>Todd Skaar, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Indiana University</name>
        <address>
          <city>Indianapolis</city>
          <state>Indiana</state>
          <zip>46202</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Todd Skaar, MD</last_name>
        <phone>317-460-9748</phone>
        <email>tskaar@iu.edu</email>
      </contact>
      <investigator>
        <last_name>Todd Skaar, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Icahn School of Medicine at Mount Sinai</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10029</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Carol Horowitz, MD</last_name>
        <phone>212-659-9567</phone>
        <email>carol.horowitz@mountsinai.org</email>
      </contact>
      <investigator>
        <last_name>Carol Horowitz, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Institute for Family Health</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10035</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Neil Calman, MD</last_name>
        <phone>212-633-0800</phone>
        <phone_ext>1255</phone_ext>
        <email>ncalman@institute.org</email>
      </contact>
      <investigator>
        <last_name>Neil Calman, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Duke University Medical Center</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27710</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Deepak Voora, MD</last_name>
        <phone>919-684-6266</phone>
        <email>deepak.voora@duke.edu</email>
      </contact>
      <investigator>
        <last_name>Deepak Voora, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Sanford Health</name>
        <address>
          <city>Fargo</city>
          <state>North Dakota</state>
          <zip>58104</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lindsey Hines, MD</last_name>
        <phone>701-234-4036</phone>
        <email>Lindsay.Hines@SanfordHealth.org</email>
      </contact>
      <investigator>
        <last_name>Lindsey Hines, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Meharry Medical College</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37208</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rajbir Singh, MD</last_name>
        <phone>615-327-6204</phone>
        <email>rsingh@mmc.edu</email>
      </contact>
      <investigator>
        <last_name>Rajbir Singh, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nashville General Hospital</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37208</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rajbir Singh, MD</last_name>
        <phone>615-327-6204</phone>
        <email>rsingh@mmc.edu</email>
      </contact>
      <investigator>
        <last_name>Rajbir Singh, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Vanderbilt University Medical Center</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37232</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Josh Peterson, MD</last_name>
        <phone>615-875-1404</phone>
        <email>josh.peterson@vumc.org</email>
      </contact>
      <investigator>
        <last_name>Josh Peterson, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pharmacogenetic</keyword>
    <keyword>CYP2D6</keyword>
    <keyword>CYP2C19</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
    </condition_browse>
    <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/NCT05966155
  org study id: PRO00104948_C
  secondary id: U01HG010225
  nct id: NCT05966155
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is comprised of three separate pharmacogenetic trials grouped into a single
        protocol due to similarities in the intervention, the hypotheses, and the trial design. The
        three trials are the Acute Pain Trial, the Chronic Pain Trial, and the Depression Trial.
        Participants can enroll in only one of the three trials. All three trials were registered on
        ClinicalTrials.gov under NCT04445792. In July 2023 each of the three treatment trials was
        registered under a separate NCT# and NCT04445792 was converted to a screening record per
        recent guidance on master protocol research programs (MPRPs). This record is specific to the
        Depression Trial within the ADOPT-PGx protocol.
  
        The Depression Trial is a prospective, multicenter, two arm randomized pragmatic trial.
        Participants meeting eligibility criteria will be randomly assigned to either immediate
        pharmacogenetic testing and genotype-guided anti-depressant therapy (Intervention arm) or
        standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators
        will test the hypothesis that pharmacogenetic testing and genotype-guided anti-depressant
        therapy will reduce depression symptoms in participants who's body processes some
        anti-depressants faster or slower than normal.
  Pain and depression are conditions that impact substantial proportions of the US population.
        Finding safe and effective drug therapies for both conditions is challenging. In the case of
        treatment for acute and chronic pain, the challenge is finding effective therapy while
        minimizing adverse effects or opioid addiction (and the ensuing consequences). For
        depression, there are few clinically relevant predictors of successful treatment leading to
        multiple trials of inadequate therapy for some patients. Both opioid and antidepressant
        prescriptions can be guided by pharmacogenetics (PGx) data based on existing guidelines from
        the Clinical Pharmacogenetics Implementation Consortium (CPIC).
  
        This study is designed to evaluate the impact of pharmacogenetic testing and genotype-guided
        pain or anti-depressant therapy on pain control or depression symptoms in a pragmatic
        setting.
  
        The rationale for examining a genotype-guided approach to acute and chronic pain management
        is based on the importance of CYP2D6 for the bioactivation of tramadol, codeine, and
        hydrocodone and data from a pilot study supporting improved pain control in intermediate and
        poor CYP2D6 metabolizers in the genotype-guided arm who are taking these drugs at baseline.
        Similarly, the rationale for examining a genotype-guided approach to depression medication
        therapy is based on the demonstrated role of CYP2D6 in the bio inactivation and CYP2C19
        oxidation of select, commonly used SSRIs. Secondly, data from industry sponsored trials
        support the hypothesis of improved depression symptom control in a genotype-guided arm.
  
        Study objectives:
  
        Determine if genotype-guided dosing or selection of antidepressants among participants with
        at least 3 months of depressive symptoms who require new or revised antidepressant therapy
        leads to improved control of depression, compared to usual care.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Immediate vs. delayed pharmacogenetic testing and genotype-guided pain or depression therapy
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 3 Month Depression Symptom Control Change from Baseline
  time frame: Baseline and 3 months
  description: Depression symptom control, defined as change in PROMIS depression T-scores from baseline to 3-months in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers
  measure: 3 Month Change in PHQ of Depression Symptomatology Change from Baseline Scores
  time frame: baseline and 3 months
  description: Change in PHQ-8 scores between baseline and 3 months in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers. Achieve 50% reduction in scores.
  measure: 3 Month Medication Side Effect Burden Change from Baseline
  time frame: 3 months
  description: Side effect burden is defined as the number of side effects experienced from a specified list of possible side effects, weighted by the severity of each side effect in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers
  measure: 3 Month Medication Adherence Change from Baseline
  time frame: 3 months
  description: Medication adherence score derived from the Voils Medication Adherence survey in genotypic or pheno-converted CYP2D6 ultra-rapid or poor metabolizers or CYP2C19 ultra-rapid, rapid, or poor metabolizers
  measure: 6 Month Depression Remission Change from Baseline
  time frame: 6 months
  description: Remission is defined as whether or not the summed raw responses to the PROMIS emotional distress depression survey is ≤ 16, corresponding to a participant respond "rarely" or "never" to most or all questions.
  arm group label: Depression - Immediate PGx Testing
  arm group type: Experimental
  description: Immediate genetic testing of CYP2D6 and CYP2C19 and clinical decisions support for antidepressant prescribing to the healthcare provider
  arm group label: Depression - Delayed PGx Testing
  arm group type: Other
  description: Delayed genetic testing of CYP2D6 and CYP2C19 and return of results after the conclusion of the 6-month follow-up period
  intervention type: Other
  intervention name: Pharmacogenetic testing
  description: Genetic testing of CYP2D6 and CYP2C19
  arm group label: Depression - Delayed PGx Testing
  arm group label: Depression - Immediate PGx Testing
  intervention type: Other
  intervention name: Clinical decisions support
  description: Prescribing recommendations to the provider based on the pharmacogenetic testing results
  arm group label: Depression - Immediate PGx Testing
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hrishikesh Chakraborty
  role: Principal Investigator
  affiliation: Duke University
  last name: Kady-Ann Steen-Burrell
  phone: 919-530-9711
  email: kady.ann.steen.burrell@duke.edu
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  country: United States
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  sharing ipd: No