<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/NCT02237937</url>
  </required_header>
  <id_info>
    <org_study_id>2011-003190-29</org_study_id>
    <nct_id>NCT02237937</nct_id>
  </id_info>
  <brief_title>Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene</brief_title>
  <official_title>Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HolsboerMaschmeyer NeuroChemie GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Max-Planck-Institute of Psychiatry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>HolsboerMaschmeyer NeuroChemie GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study evaluates the ABCB1-genotype dependent efficacy of a quick dose-escalation strategy&#xD;
      within 28 days of treatment with approved antidepressants that are known substrates of the&#xD;
      P-glycoprotein, an efflux pump of the blood-brain barrier expressed by the ABCB1 gene.&#xD;
&#xD;
      Moreover, the study evaluates ABCB1-genotype dependent side-effects of approved&#xD;
      antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the&#xD;
      blood-brain barrier expressed by the ABCB1 gene.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2011</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>25% improvement in the HAM-D</measure>
    <time_frame>after 28 days of treatment</time_frame>
    <description>Partial response indicated by at least 25% improvement in the Hamilton Rating Scale for Depression (HAM-D)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>side effects</measure>
    <time_frame>after 28 days of treatment</time_frame>
    <description>UKU side effect scale, AMDP side effect scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Major Depression</condition>
  <arm_group>
    <arm_group_label>Normal dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Selected antidepressants that are substrates of the P-glycoprotein:&#xD;
Dosage:&#xD;
paroxetine &lt; 40 mg/d&#xD;
sertraline &lt; 100 mg/d&#xD;
citalopram &lt; 40 mg/d&#xD;
escitalopram &lt; 20 mg/d&#xD;
venlafaxine &lt; 225 mg/d&#xD;
amitriptyline &lt; 150 mg/d&#xD;
amitriptylinoxide &lt; 150 mg/d&#xD;
nortriptyline &lt; 150 mg/d&#xD;
trimipramine &lt; 150 mg/d</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Selected antidepressants that are substrates of the P-glycoprotein:&#xD;
Dosage:&#xD;
paroxetine &lt; 80 mg/d&#xD;
sertraline &lt; 200 mg/d&#xD;
citalopram &lt; 80 mg/d&#xD;
escitalopram &lt; 40 mg/d&#xD;
venlafaxine &lt; 450 mg/d&#xD;
amitriptyline &lt; 300 mg/d&#xD;
amitriptylinoxide &lt; 300 mg/d&#xD;
nortriptyline &lt; 300 mg/d&#xD;
trimipramine &lt; 300 mg/d</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paroxetine</intervention_name>
    <arm_group_label>High dosage</arm_group_label>
    <arm_group_label>Normal dosage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sertraline</intervention_name>
    <arm_group_label>High dosage</arm_group_label>
    <arm_group_label>Normal dosage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Citalopram</intervention_name>
    <arm_group_label>High dosage</arm_group_label>
    <arm_group_label>Normal dosage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venlafaxine</intervention_name>
    <arm_group_label>High dosage</arm_group_label>
    <arm_group_label>Normal dosage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amitriptyline</intervention_name>
    <arm_group_label>High dosage</arm_group_label>
    <arm_group_label>Normal dosage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Escitalopram</intervention_name>
    <arm_group_label>High dosage</arm_group_label>
    <arm_group_label>Normal dosage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amitriptylinoxide</intervention_name>
    <arm_group_label>High dosage</arm_group_label>
    <arm_group_label>Normal dosage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nortriptyline</intervention_name>
    <arm_group_label>High dosage</arm_group_label>
    <arm_group_label>Normal dosage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trimipramine</intervention_name>
    <arm_group_label>High dosage</arm_group_label>
    <arm_group_label>Normal dosage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients&#xD;
&#xD;
          -  Age between 18 and 80 years&#xD;
&#xD;
          -  Inpatients with a DSM-IV diagnosis of Major Depression&#xD;
&#xD;
          -  single episode or recurrent&#xD;
&#xD;
          -  moderate to severe intensity&#xD;
&#xD;
          -  without psychotic features&#xD;
&#xD;
          -  Inpatients with a DSM-IV diagnosis of bipolar disorder I or II&#xD;
&#xD;
          -  current episode with depressive symptoms&#xD;
&#xD;
          -  moderate to severe intensity&#xD;
&#xD;
          -  without psychotic features&#xD;
&#xD;
          -  HAM-D score at the time of inclusion in the study ≥ 14&#xD;
&#xD;
          -  Patient has already been adjusted to one of the following antidepressants in a dose&#xD;
             which is still under the defined normal-dose:&#xD;
&#xD;
          -  paroxetine &lt; 40 mg/d&#xD;
&#xD;
          -  sertraline &lt; 100 mg/d&#xD;
&#xD;
          -  citalopram &lt; 40 mg/d&#xD;
&#xD;
          -  escitalopram &lt; 20 mg/d&#xD;
&#xD;
          -  venlafaxine &lt; 225 mg/d&#xD;
&#xD;
          -  amitriptyline &lt; 150 mg/d&#xD;
&#xD;
          -  amitriptylinoxide &lt; 150 mg/d&#xD;
&#xD;
          -  nortriptyline &lt; 150 mg/d&#xD;
&#xD;
          -  trimipramine &lt; 150 mg/d&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute suicidality (HAM-D Item 3 score &gt; 2)&#xD;
&#xD;
          -  Acute alcohol-, hypnotics-, analgesics- or psychopharmacological intoxication or&#xD;
             delirium&#xD;
&#xD;
          -  Current alcohol dependence, or dependencies from other psychotropic substances&#xD;
&#xD;
          -  Severe medical or neurological diseases: patients with severe hepatic (severe&#xD;
             impairment of liver function, cirrhosis of the liver), renal (kidney malfunctions),&#xD;
             cardiovascular (recent myocardial infarction, instable heart disease), neurological&#xD;
             diseases (e.g. multiple sclerosis, Parkinson, dementia)&#xD;
&#xD;
          -  Patients incapable of giving informed consent&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Women of reproductive age without effective contraception&#xD;
&#xD;
          -  Simultaneous participation in other clinical trials or participation in an other&#xD;
             clinical trial within 6 weeks before the start of the study&#xD;
&#xD;
          -  Hypersensitivity to the study medication or to one of the ingredients of the&#xD;
             medication&#xD;
&#xD;
          -  Simultaneous treatment with another antidepressant besides study medication&#xD;
             (exception: trazodone up to 75 mg/d, mirtazapine up to 15 mg/d, trimipramine up to 50&#xD;
             mg/d)&#xD;
&#xD;
          -  Simultaneous treatment with mood stabilizers or neuroleptic drugs (exception:&#xD;
             quetiapine up to 50 mg/d, olanzapine up to 5 mg/d)&#xD;
&#xD;
          -  Exclusion criteria of the study medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Florian Holsboer, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Max-Planck-Institute of Psychiatry</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Barbara Breitenstein, MSc</last_name>
    <phone>0049 89 30622</phone>
    <phone_ext>244</phone_ext>
    <email>barbara_breitenstein@mpipsykl.mpg.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Max Planck Institute of Psychiatry</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>80804</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Barbara Breitenstein, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 26, 2013</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression, Affective Disorder</keyword>
  <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>Amitriptyline</mesh_term>
    <mesh_term>Citalopram</mesh_term>
    <mesh_term>Paroxetine</mesh_term>
    <mesh_term>Venlafaxine Hydrochloride</mesh_term>
    <mesh_term>Sertraline</mesh_term>
    <mesh_term>Nortriptyline</mesh_term>
    <mesh_term>Trimipramine</mesh_term>
    <mesh_term>Escitalopram</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/NCT02237937
org study id: 2011-003190-29
nct id: NCT02237937
lead sponsor: 
collaborator: 
has dmc: No
The study evaluates the ABCB1-genotype dependent efficacy of a quick dose-escalation strategy
      within 28 days of treatment with approved antidepressants that are known substrates of the
      P-glycoprotein, an efflux pump of the blood-brain barrier expressed by the ABCB1 gene.

      Moreover, the study evaluates ABCB1-genotype dependent side-effects of approved
      antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the
      blood-brain barrier expressed by the ABCB1 gene.
allocation: Randomized
intervention model: Single Group Assignment
masking: Double (Investigator, Outcomes Assessor)
measure: 25% improvement in the HAM-D
time frame: after 28 days of treatment
description: Partial response indicated by at least 25% improvement in the Hamilton Rating Scale for Depression (HAM-D)
measure: side effects
time frame: after 28 days of treatment
description: UKU side effect scale, AMDP side effect scale
arm group label: Normal dosage
arm group type: Experimental
description: Selected antidepressants that are substrates of the P-glycoprotein:
Dosage:
paroxetine < 40 mg/d
sertraline < 100 mg/d
citalopram < 40 mg/d
escitalopram < 20 mg/d
venlafaxine < 225 mg/d
amitriptyline < 150 mg/d
amitriptylinoxide < 150 mg/d
nortriptyline < 150 mg/d
trimipramine < 150 mg/d
arm group label: High dosage
arm group type: Experimental
description: Selected antidepressants that are substrates of the P-glycoprotein:
Dosage:
paroxetine < 80 mg/d
sertraline < 200 mg/d
citalopram < 80 mg/d
escitalopram < 40 mg/d
venlafaxine < 450 mg/d
amitriptyline < 300 mg/d
amitriptylinoxide < 300 mg/d
nortriptyline < 300 mg/d
trimipramine < 300 mg/d
intervention type: Drug
intervention name: Paroxetine
arm group label: High dosage
arm group label: Normal dosage
intervention type: Drug
intervention name: Sertraline
arm group label: High dosage
arm group label: Normal dosage
intervention type: Drug
intervention name: Citalopram
arm group label: High dosage
arm group label: Normal dosage
intervention type: Drug
intervention name: Venlafaxine
arm group label: High dosage
arm group label: Normal dosage
intervention type: Drug
intervention name: Amitriptyline
arm group label: High dosage
arm group label: Normal dosage
intervention type: Drug
intervention name: Escitalopram
arm group label: High dosage
arm group label: Normal dosage
intervention type: Drug
intervention name: Amitriptylinoxide
arm group label: High dosage
arm group label: Normal dosage
intervention type: Drug
intervention name: Nortriptyline
arm group label: High dosage
arm group label: Normal dosage
intervention type: Drug
intervention name: Trimipramine
arm group label: High dosage
arm group label: Normal dosage
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Florian Holsboer, MD, PHD
role: Principal Investigator
affiliation: Max-Planck-Institute of Psychiatry
last name: Barbara Breitenstein, MSc
phone: 0049 89 30622
phone ext: 244
email: barbara_breitenstein@mpipsykl.mpg.de
facility: 
status: Recruiting
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Depression
mesh term: Amitriptyline
mesh term: Citalopram
mesh term: Paroxetine
mesh term: Venlafaxine Hydrochloride
mesh term: Sertraline
mesh term: Nortriptyline
mesh term: Trimipramine
mesh term: Escitalopram