<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/NCT03232502</url>
  </required_header>
  <id_info>
    <org_study_id>Pending1</org_study_id>
    <nct_id>NCT03232502</nct_id>
  </id_info>
  <brief_title>Pharmacogenetics in Primary Care Psychotropics</brief_title>
  <official_title>Pharmacogenetics in Primary Care Psychotropics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <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>
      Pragmatic trial of pharmacogenetic testing at the time of prescription for a selective&#xD;
      serotonin reuptake inhibitor, tricyclic antidepressant or atypical antipsychotic. Does real&#xD;
      time intervention improve patient outcomes?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 15, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">January 15, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient oriented outcome1- Clinical Improvement</measure>
    <time_frame>6 months</time_frame>
    <description>Clinically significant improvement as noted by physician (Subjective and PHQ-9)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient oriented outcome2- Adverse effects</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients with specific, common side effects (from medical chart)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient oriented outcome3- Time to Improvement</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Days to clinical improvement (from medical chart)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient oriented outcome5- Visits</measure>
    <time_frame>6 months</time_frame>
    <description>Total number of visits to clinic with medication titration required (from medical chart)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Depression</condition>
  <condition>Obsessive-Compulsive Disorder</condition>
  <condition>Generalized Anxiety Disorder</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pharmacogenetic testing</intervention_name>
    <description>Basic pharmacogenetic panel</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18&#xD;
&#xD;
          -  Prescribed a drug of interest for the first time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous pharmacogenetic testing available&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03232502
org study id: Pending1
nct id: NCT03232502
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Pragmatic trial of pharmacogenetic testing at the time of prescription for a selective
      serotonin reuptake inhibitor, tricyclic antidepressant or atypical antipsychotic. Does real
      time intervention improve patient outcomes?
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient oriented outcome1- Clinical Improvement
time frame: 6 months
description: Clinically significant improvement as noted by physician (Subjective and PHQ-9)
measure: Patient oriented outcome2- Adverse effects
time frame: 6 months
description: Number of patients with specific, common side effects (from medical chart)
measure: Patient oriented outcome3- Time to Improvement
time frame: Up to 6 months
description: Days to clinical improvement (from medical chart)
measure: Patient oriented outcome5- Visits
time frame: 6 months
description: Total number of visits to clinic with medication titration required (from medical chart)
arm group label: Control
arm group type: No Intervention
arm group label: Intervention
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: Pharmacogenetic testing
description: Basic pharmacogenetic panel
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Anxiety Disorders
mesh term: Obsessive-Compulsive Disorder
sharing ipd: Undecided