<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/NCT03228953</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR4283</org_study_id>
    <nct_id>NCT03228953</nct_id>
  </id_info>
  <brief_title>Pharmacogenomic Testing in Major Depressive Disorder</brief_title>
  <official_title>Impact of Comprehensive Pharmacogenomic Testing on the Treatment of Major Depressive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a two-arm double-blind prospective randomized controlled trial (RCT) to evaluate&#xD;
      clinical impact of pharmacogenomic testing on the treatment of major depressive disorder.&#xD;
      Participants will be randomly assigned to two groups: pharmacogenomic-guided therapy group&#xD;
      (guided group) and treatment as usual group (TAU group). The primary hypothesis is the&#xD;
      pharmacogenomic-guided treatment group will demonstrate significantly higher percent&#xD;
      improvement in depression score compared to treatment-as-usual group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To a large extent, variability in antidepressant efficacy can be explained by genetic&#xD;
      variations that affect medication-metabolizing enzymes, drug transporters, and medication&#xD;
      targets. Recent reviews demonstrated significant potential of pharmacogenomic testing in&#xD;
      improving treatment of major depressive disorder. One of the major barriers towards&#xD;
      successful implementation of pharmacogenomic testing for patients with major depressive&#xD;
      disorder is lack of systematic evaluation of impact of this approach in routine clinical care&#xD;
      settings. The major goal of this study is to systematically evaluate impact of comprehensive&#xD;
      pharmacogenomic testing on the treatment of major depressive disorder in ambulatory setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Investigator retired.&#xD;
  </why_stopped>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">July 17, 2019</completion_date>
  <primary_completion_date type="Actual">July 17, 2019</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Score on the Hamilton Rating Scale for Depression (HAMD-17)</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>The patient is rated by a clinician among 17 dimensions with a score on a 3 or 5 point scale. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score on Subject-Rated 16-item Quick Inventory of Depression Symptomatology Scales (QIDS-SR)</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>The Quick Inventory of Depressive Symptomatology is a short screening tool based on the larger Inventory of Depressive Symptomatology (IDS). Each item is scored on a scale from 0 to 3 points. Total scores range from 0 (no depression) to 27 (severe depression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on the 9-item Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day). Higher PHQ-9 scores are associated with decreased functional status and increased symptom-related difficulties, sick days and healthcare utilization.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Pharmacogenomic-guided therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, results of pharmacogenomic testing will be provided to the treating physician within 2-5 working days. Thus, the patient's treatment provider will be able begin antidepressant adjustments based on pharmacogenomic testing report within a week of the baseline visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual (TAU) group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>For patients randomized to this group, medication treatment decisions by the treating clinicians will be made without the availability of the pharmacogenomic report; however, the test results will be provided after the study completion to the patient treating physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacogenomic testing</intervention_name>
    <description>Pharmacogenomic testing is delivered to treating providers of patients with major depressive disorder</description>
    <arm_group_label>Pharmacogenomic-guided therapy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of major depressive disorder (MDD)&#xD;
&#xD;
          2. Prescription of index antidepressant medications&#xD;
&#xD;
          3. Minimum score of 14 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of bipolar disorder (any type), schizophrenia, or schizoaffective disorders&#xD;
&#xD;
          2. Active diagnosis of substance abuse or dependence&#xD;
&#xD;
          3. Current suicidal ideation&#xD;
&#xD;
          4. Previous suicidal attempts&#xD;
&#xD;
          5. A person has already had pharmacogenetic testing done.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manuel Cabrera, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>October 10, 2022</last_update_submitted>
  <last_update_submitted_qc>October 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacogenomic testing</keyword>
  <keyword>Depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03228953
org study id: AAAR4283
nct id: NCT03228953
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a two-arm double-blind prospective randomized controlled trial (RCT) to evaluate
      clinical impact of pharmacogenomic testing on the treatment of major depressive disorder.
      Participants will be randomly assigned to two groups: pharmacogenomic-guided therapy group
      (guided group) and treatment as usual group (TAU group). The primary hypothesis is the
      pharmacogenomic-guided treatment group will demonstrate significantly higher percent
      improvement in depression score compared to treatment-as-usual group.
To a large extent, variability in antidepressant efficacy can be explained by genetic
      variations that affect medication-metabolizing enzymes, drug transporters, and medication
      targets. Recent reviews demonstrated significant potential of pharmacogenomic testing in
      improving treatment of major depressive disorder. One of the major barriers towards
      successful implementation of pharmacogenomic testing for patients with major depressive
      disorder is lack of systematic evaluation of impact of this approach in routine clinical care
      settings. The major goal of this study is to systematically evaluate impact of comprehensive
      pharmacogenomic testing on the treatment of major depressive disorder in ambulatory setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Score on the Hamilton Rating Scale for Depression (HAMD-17)
time frame: Up to 10 weeks
description: The patient is rated by a clinician among 17 dimensions with a score on a 3 or 5 point scale. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial.
measure: Score on Subject-Rated 16-item Quick Inventory of Depression Symptomatology Scales (QIDS-SR)
time frame: Up to 10 weeks
description: The Quick Inventory of Depressive Symptomatology is a short screening tool based on the larger Inventory of Depressive Symptomatology (IDS). Each item is scored on a scale from 0 to 3 points. Total scores range from 0 (no depression) to 27 (severe depression).
measure: Score on the 9-item Patient Health Questionnaire (PHQ-9)
time frame: Up to 10 weeks
description: The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Higher PHQ-9 scores are associated with decreased functional status and increased symptom-related difficulties, sick days and healthcare utilization.
arm group label: Pharmacogenomic-guided therapy group
arm group type: Experimental
description: In this group, results of pharmacogenomic testing will be provided to the treating physician within 2-5 working days. Thus, the patient's treatment provider will be able begin antidepressant adjustments based on pharmacogenomic testing report within a week of the baseline visit.
arm group label: Treatment as usual (TAU) group
arm group type: No Intervention
description: For patients randomized to this group, medication treatment decisions by the treating clinicians will be made without the availability of the pharmacogenomic report; however, the test results will be provided after the study completion to the patient treating physician.
intervention type: Other
intervention name: Pharmacogenomic testing
description: Pharmacogenomic testing is delivered to treating providers of patients with major depressive disorder
arm group label: Pharmacogenomic-guided therapy group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Manuel Cabrera, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
sharing ipd: No