<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/NCT04507555</url>
  </required_header>
  <id_info>
    <org_study_id>PrePGx_ex20Mikoteit</org_study_id>
    <nct_id>NCT04507555</nct_id>
  </id_info>
  <brief_title>Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy</brief_title>
  <acronym>PrePGx</acronym>
  <official_title>Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PD Dr. med. Thorsten Mikoteit</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Psychiatrische Dienste Solothurn</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Privatklinik Wyss</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Basel</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study at the Solothurn Psychiatric Clinic, the investigators compare the&#xD;
      effectiveness and tolerability of antidepressant pharmacotherapy in three groups. In the&#xD;
      intervention group, the physician selects and doses the medication for depression based on a&#xD;
      pharmacogenetic examination conducted by a clinical pharmacist. In the standard group, the&#xD;
      treating physician selects and doses the antidepressant drug without the support of genetic&#xD;
      testing, in accordance with current standard practice. If after the first week of&#xD;
      hopsitalization no adjustment to a new antidepressant is necessary, the investigators will&#xD;
      monitor the progress of these patients until they leave the clinic in an observational arm.&#xD;
      The drugs used are all approved in Switzerland for the treatment of depression.&#xD;
      Classification into the intervention or standard group is made randomly after the first week&#xD;
      of hospitalisation, if the treating physician deems it necessary to change or readjust the&#xD;
      antidepressant pharmacotherapy. The probability of allocation to one of the two study groups&#xD;
      is 50%. All study participants will be hospitalized for at least five weeks and monitored&#xD;
      until they leave the clinic. In total, it is planned to include and examine 95 patients each&#xD;
      into the intervention and standard group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>rate of response to the antidepressant therapy at the end of week 4</measure>
    <time_frame>28 days</time_frame>
    <description>response is determined as a reduction in the Hamilton Depression (HAM-D17) Scale score of at least 50 % of the baseline value</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to response</measure>
    <time_frame>28 days</time_frame>
    <description>time span from start of antidepressant pharmacotherapy until first assessed response (= HAM-D17 reduction of at least 50 % compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission rate</measure>
    <time_frame>28 days</time_frame>
    <description>17 item Hamilton rating scale for Depression (HAM-D17) score ≤ 8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall change in 17 item Hamilton rating scale for Depression (HAM-D17) from baseline to week 4</measure>
    <time_frame>28 days</time_frame>
    <description>minimum value: 0, maximum value: 52 ; higher scores mean worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time till discharge</measure>
    <time_frame>assessed up to 3 month</time_frame>
    <description>time span from admission (randomization) to discharge from inpatient treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient depression self-rating</measure>
    <time_frame>28 days</time_frame>
    <description>two weekly assessment with Beck's Depression Inventory questionnaire (BDI-II)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effect measure (self-rated frequency, intensity and burden of side effects, FIBSER score)</measure>
    <time_frame>28 days</time_frame>
    <description>weekly assessment, minimum value: 0, maximum value: 18 ; higher scores mean worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events related to antidepressant pharmacotherapy</measure>
    <time_frame>28 days</time_frame>
    <description>severity grading ≥ 2 (using CTCAE version 5.0) and causality to antidepressant pharmacotherapy assessed as possible, probable or definite</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing</intervention_name>
    <description>The study intervention is the service of pharmacist guided pre-emptive PGx testing to support clinical decision making for antidepressant selection and dosing.&#xD;
This service involves genotyping and thereof evidence-based genotype interpretation commercially offered as Stratipharm® (humatrix AG, Pfungstadt Germany, https://www.stratipharm.de). Furthermore, clinical pharmacists will process and evaluate the results from PGx testing (Stratipharm®) in context of the individual patient medication history as well as current co-medication and forward an individualized recommendation for antidepressant selection and dosing to the treating psychiatrist.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard care antidepressant selection and dosing</intervention_name>
    <description>Selection and dosing of the new antidepressant pharmacotherapy will be determined by the treating investigator alone, according to current standard of care considering clinical factors only.</description>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years old&#xD;
&#xD;
          -  Diagnosis unipolar moderate or severe depressive episode or recurrent depressive&#xD;
             disorder (ICD10: F32.1/32.2/33.1/33.2)&#xD;
&#xD;
          -  HAM-D17 ≥ 17&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute suicide risk&#xD;
&#xD;
          -  Psychotic symptomatology&#xD;
&#xD;
          -  Other acute serious psychiatric disorder other than depression&#xD;
&#xD;
          -  Excessive consumption of alcohol and/or drugs&#xD;
&#xD;
          -  Severe acute - or severe chronic somatic diseases&#xD;
&#xD;
          -  Pregnant / lactating women&#xD;
&#xD;
          -  Under current treatment with fluoxetine&#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>Thorsten Mikoteit, PD Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Psychiatrische Dienste Solothurn</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Céline Stäuble, MSc</last_name>
    <phone>+41 61 207 61 78</phone>
    <email>celine.staeuble@unibas.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Privatklinik Wyss</name>
      <address>
        <city>Münchenbuchsee</city>
        <state>Bern</state>
        <zip>3053</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Imboden, Dr. med.</last_name>
      <phone>+4131 868 33 33</phone>
      <email>info@privatklinik-wyss.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Psychiatrische Dienste Solothurn</name>
      <address>
        <city>Solothurn</city>
        <zip>4503</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thorsten Mikoteit, PD Dr. med.</last_name>
      <phone>+41 32 627 11 11</phone>
      <email>thorsten.mikoteit@spital.so.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Basel</investigator_affiliation>
    <investigator_full_name>PD Dr. med. Thorsten Mikoteit</investigator_full_name>
    <investigator_title>Deputy Head Physician Division Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antidepressive Agents</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04507555
org study id: PrePGx_ex20Mikoteit
nct id: NCT04507555
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study at the Solothurn Psychiatric Clinic, the investigators compare the
      effectiveness and tolerability of antidepressant pharmacotherapy in three groups. In the
      intervention group, the physician selects and doses the medication for depression based on a
      pharmacogenetic examination conducted by a clinical pharmacist. In the standard group, the
      treating physician selects and doses the antidepressant drug without the support of genetic
      testing, in accordance with current standard practice. If after the first week of
      hopsitalization no adjustment to a new antidepressant is necessary, the investigators will
      monitor the progress of these patients until they leave the clinic in an observational arm.
      The drugs used are all approved in Switzerland for the treatment of depression.
      Classification into the intervention or standard group is made randomly after the first week
      of hospitalisation, if the treating physician deems it necessary to change or readjust the
      antidepressant pharmacotherapy. The probability of allocation to one of the two study groups
      is 50%. All study participants will be hospitalized for at least five weeks and monitored
      until they leave the clinic. In total, it is planned to include and examine 95 patients each
      into the intervention and standard group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: rate of response to the antidepressant therapy at the end of week 4
time frame: 28 days
description: response is determined as a reduction in the Hamilton Depression (HAM-D17) Scale score of at least 50 % of the baseline value
measure: Time to response
time frame: 28 days
description: time span from start of antidepressant pharmacotherapy until first assessed response (= HAM-D17 reduction of at least 50 % compared to baseline
measure: Remission rate
time frame: 28 days
description: 17 item Hamilton rating scale for Depression (HAM-D17) score ≤ 8
measure: Overall change in 17 item Hamilton rating scale for Depression (HAM-D17) from baseline to week 4
time frame: 28 days
description: minimum value: 0, maximum value: 52 ; higher scores mean worse outcome
measure: Time till discharge
time frame: assessed up to 3 month
description: time span from admission (randomization) to discharge from inpatient treatment
measure: Patient depression self-rating
time frame: 28 days
description: two weekly assessment with Beck's Depression Inventory questionnaire (BDI-II)
measure: Side effect measure (self-rated frequency, intensity and burden of side effects, FIBSER score)
time frame: 28 days
description: weekly assessment, minimum value: 0, maximum value: 18 ; higher scores mean worse outcome
measure: Number of adverse events related to antidepressant pharmacotherapy
time frame: 28 days
description: severity grading ≥ 2 (using CTCAE version 5.0) and causality to antidepressant pharmacotherapy assessed as possible, probable or definite
arm group label: Intervention
arm group type: Experimental
arm group label: Standard Care
arm group type: Active Comparator
arm group label: Observational
arm group type: No Intervention
intervention type: Procedure
intervention name: Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing
description: The study intervention is the service of pharmacist guided pre-emptive PGx testing to support clinical decision making for antidepressant selection and dosing.
This service involves genotyping and thereof evidence-based genotype interpretation commercially offered as Stratipharm® (humatrix AG, Pfungstadt Germany, https://www.stratipharm.de). Furthermore, clinical pharmacists will process and evaluate the results from PGx testing (Stratipharm®) in context of the individual patient medication history as well as current co-medication and forward an individualized recommendation for antidepressant selection and dosing to the treating psychiatrist.
arm group label: Intervention
intervention type: Procedure
intervention name: Standard care antidepressant selection and dosing
description: Selection and dosing of the new antidepressant pharmacotherapy will be determined by the treating investigator alone, according to current standard of care considering clinical factors only.
arm group label: Standard Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thorsten Mikoteit, PD Dr. med.
role: Principal Investigator
affiliation: Psychiatrische Dienste Solothurn
last name: Céline Stäuble, MSc
phone: +41 61 207 61 78
email: celine.staeuble@unibas.ch
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University of Basel
investigator full name: PD Dr. med. Thorsten Mikoteit
investigator title: Deputy Head Physician Division Psychiatry
mesh term: Depression
mesh term: Antidepressive Agents