<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/NCT02992496</url>
  </required_header>
  <id_info>
    <org_study_id>v1.2_20161024</org_study_id>
    <nct_id>NCT02992496</nct_id>
  </id_info>
  <brief_title>Investigation of Antidepressant Efficacy of Oral Ketamine Treatment</brief_title>
  <official_title>Investigation of Antidepressant Efficacy of Oral Ketamine Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      The purpose of this double-blind, controlled, randomized study is to investigate the&#xD;
      antidepressant efficacy of oral ketamine treatment in patients suffering from a major&#xD;
      depressive episode.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 24, 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Montgomery-Åsberg Depression Rating Scale (MADRS)</measure>
    <time_frame>1 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinician Administered Dissociative States Scale (CADSS)</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Depression Rating Scale</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Major Depressive Episode</condition>
  <arm_group>
    <arm_group_label>Ketamine treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each patient will undergo six treatment sessions with 1mg/kg oral ketamine over 2 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each patient will undergo six treatment sessions with 0.03mg/kg oral midazolam over 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>1mg/kg, 6 applications over 2 weeks</description>
    <arm_group_label>Ketamine treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam Hydrochloride</intervention_name>
    <description>0.03mg/kg, 6 applications over 2 weeks</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of a major depressive episode in the scope of a major depressive or bipolar&#xD;
             disorder supported by a Structured Clinical Interview for DSM-IV-TR (SCID)&#xD;
&#xD;
          -  Hamilton depression rating scale score ≥ 19&#xD;
&#xD;
          -  Willingness and competence to sign the informed consent form&#xD;
&#xD;
          -  Stable psychopharmacological treatment for 10 days (except benzodiazepines)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Initiation of a new antidepressant or mood stabilizing treatment (pharmacological,&#xD;
             physical or psychotherapeutic) with adequate dosage (as defined by the minimum&#xD;
             recommended dose in the respective prescribing information) within 4 weeks prior to&#xD;
             inclusion&#xD;
&#xD;
          -  Prior use of ketamine&#xD;
&#xD;
          -  Pregnancy/Breast feeding&#xD;
&#xD;
          -  Instable arterial hypertension &gt;170/110mmHg&#xD;
&#xD;
          -  Hepatic dysfunction&#xD;
&#xD;
          -  Hyperthyreosis&#xD;
&#xD;
          -  History of glaucoma&#xD;
&#xD;
          -  Neurodegenerative disorders&#xD;
&#xD;
          -  Any unstable medical illness&#xD;
&#xD;
          -  History of substance abuse within the past 12 months&#xD;
&#xD;
          -  History of psychosis&#xD;
&#xD;
          -  Failure to comply with the study protocol or to follow the instructions of the&#xD;
             investigating team&#xD;
&#xD;
          -  Current treatment with one of the following drugs: clopidogrel, carbamazepine,&#xD;
             valproate, barbiturates, memantine, modafinil, disulfiram, amiodarone, ranolazine,&#xD;
             phenytoin, verapamil, fibrates, antiretroviral agents, antimicrobial&#xD;
             chemotherapeutics, azole antifungals, glucocorticoids, cyclosporine,&#xD;
             valeriana/garlic/grapefruit preparations, St. John's wort.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Psychiatry and Psychotherapy, Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rupert Lanzenberger, A/Prof.</last_name>
      <phone>+43 40400</phone>
      <phone_ext>35760</phone_ext>
      <email>rupert.lanzenberger@meduniwien.ac.at</email>
    </contact>
    <investigator>
      <last_name>Rupert Lanzenberger, A/Prof. MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>August 30, 2019</last_update_submitted>
  <last_update_submitted_qc>August 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Rupert Lanzenberger</investigator_full_name>
    <investigator_title>Assoc.-Prof., MD PD</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Ketamine</mesh_term>
  </intervention_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/NCT02992496
org study id: v1.2_20161024
nct id: NCT02992496
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this double-blind, controlled, randomized study is to investigate the
      antidepressant efficacy of oral ketamine treatment in patients suffering from a major
      depressive episode.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
time frame: 1 week
measure: Clinician Administered Dissociative States Scale (CADSS)
time frame: 2 weeks
measure: Hamilton Depression Rating Scale
time frame: 1 week
arm group label: Ketamine treatment group
arm group type: Active Comparator
description: Each patient will undergo six treatment sessions with 1mg/kg oral ketamine over 2 weeks.
arm group label: Control group
arm group type: Active Comparator
description: Each patient will undergo six treatment sessions with 0.03mg/kg oral midazolam over 2 weeks
intervention type: Drug
intervention name: Ketamine
description: 1mg/kg, 6 applications over 2 weeks
arm group label: Ketamine treatment group
intervention type: Drug
intervention name: Midazolam Hydrochloride
description: 0.03mg/kg, 6 applications over 2 weeks
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Rupert Lanzenberger
investigator title: Assoc.-Prof., MD PD
mesh term: Midazolam
mesh term: Ketamine
sharing ipd: No