<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/NCT03766867</url>
  </required_header>
  <id_info>
    <org_study_id>17915A</org_study_id>
    <nct_id>NCT03766867</nct_id>
  </id_info>
  <brief_title>Vortioxetine Intravenous Infusion at Initiation of Oral Treatment With Vortioxetine in Patients With Depression</brief_title>
  <official_title>Interventional, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Initial Administration of 25 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lundbeck A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H. Lundbeck A/S</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>
      The purpose of this study is to evaluate the efficacy and safety of vortioxetine given as a&#xD;
      single intravenous dose of 25 mg at initiation of an oral vortioxetine regimen of 10 mg/day&#xD;
      for 7 days&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consists of a 7-day double-blind Treatment Period (Day 0 to Day 6)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">August 28, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline (Day 0) to Day 1 (24 h post-infusion) in MADRS-6 subscale score</measure>
    <time_frame>From baseline (Day 0) to Day 1 (24 h post-infusion)</time_frame>
    <description>The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The primary endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline (Day 0) to Day 3 in MADRS-6 subscale score</measure>
    <time_frame>From baseline (Day 0) to Day 3</time_frame>
    <description>The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline (Day 0) to Day 7 in MADRS-6 subscale score</measure>
    <time_frame>From baseline (Day 0) to Day 7</time_frame>
    <description>The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in MADRS total score from baseline to Day 1, Day 3, Day 7</measure>
    <time_frame>From baseline to Day 1, Day 3, Day 7</time_frame>
    <description>The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>≥50% decrease in MADRS total score from baseline on Day 1 and Day 3</measure>
    <time_frame>On Day 1 and Day 3</time_frame>
    <description>The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGI-I score at Day 1, Day 3, Day 7</measure>
    <time_frame>At Day 1, Day 3, Day 7</time_frame>
    <description>The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGI-I response (defined as CGI-I score ≤2) on Day 1 and 3</measure>
    <time_frame>At Day 1 and 3</time_frame>
    <description>The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in CGI-S score to Day 1, Day 3, Day 7</measure>
    <time_frame>From baseline to Day 1, Day 3, Day 7</time_frame>
    <description>The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F of vortioxetine</measure>
    <time_frame>Day 0, Day 1, Day 7</time_frame>
    <description>Total plasma clearance of vortioxetine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cav</measure>
    <time_frame>Day 0, Day 1, Day 7</time_frame>
    <description>average plasma concentration during a steady-state day</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Vortioxetine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vortioxetine infusion 25 mg</intervention_name>
    <description>1 mg/mL, concentrate for solution for infusion, 25 mL (25 mg) administered in 250 mL saline over 2 hours as single dose for 7 days</description>
    <arm_group_label>Vortioxetine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vortioxetine tablets 10 mg/day</intervention_name>
    <description>10 mg, tablets, oral administration once daily</description>
    <arm_group_label>Vortioxetine</arm_group_label>
    <other_name>Brintellix ®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo infusion</intervention_name>
    <description>concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo tablets</intervention_name>
    <description>oral administration once daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient has recurrent MDD, diagnosed according to DSM-5® and confirmed using the&#xD;
             Mini-International Neuropsychiatric Interview (MINI).&#xD;
&#xD;
          -  The patient has a MADRS total score ≥ 30 at the Screening Visit.&#xD;
&#xD;
          -  As part of standard of care treatment, the patient is to be admitted to hospital due&#xD;
             to the severity of the depressive symptoms and is willing to remain hospitalized for&#xD;
             the duration of the study treatment period.&#xD;
&#xD;
          -  The patient has had the current MDE for ≥3 months but less than 12 months.&#xD;
&#xD;
          -  The patient has received treatment for the current episode with an SSRI/SNRI&#xD;
             monotherapy (citalopram, escitalopram, paroxetine, duloxetine, venlafaxine,&#xD;
             sertraline) at an approved dose for at least 6 weeks.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        -The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria),&#xD;
        established as the primary diagnosis, other than MDD, as assessed using the MINI or another&#xD;
        diagnostic interview&#xD;
&#xD;
        Other in- and exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Email contact via H. Lundbeck A/S</last_name>
    <role>Study Director</role>
    <affiliation>LundbeckClinicalTrials@Lundbeck.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD (BG1004)</name>
      <address>
        <city>Burgas</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPH - Kardzhali, EOOD (BG1005)</name>
      <address>
        <city>Kardzhali</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT &quot;Dr. Hristo Stambolski&quot;, EOOD (BG1001)</name>
      <address>
        <city>Kazanlak</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Psychiatric Hospital &quot;Sv. Ivan Rilski&quot; (BG1009)</name>
      <address>
        <city>Novi Iskar</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT 'Dr. Georgi Stranski', EAD (BG1006)</name>
      <address>
        <city>Pleven</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHC - Ruse, EOOD (BG1007)</name>
      <address>
        <city>Ruse</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Psychiatric Hospital (BG1008)</name>
      <address>
        <city>Tsarev Brod</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mental Health Center-Vratsa EOOD (BG1002)</name>
      <address>
        <city>Vratsa</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marienthali Kliinik (EE2001)</name>
      <address>
        <city>Tallinn</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tartu University Hospital (EE2002)</name>
      <address>
        <city>Tartu</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psychoneurological Hospital of Daugavpils (LV3003)</name>
      <address>
        <city>Daugavpils</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riga Centre of Psychiatry and Narcology (LV3002)</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psychoneurological Hospital of Strenci (LV3001)</name>
      <address>
        <city>Strenči</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Estonia</country>
    <country>Latvia</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>August 28, 2019</last_update_submitted>
  <last_update_submitted_qc>August 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2019</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>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vortioxetine</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/NCT03766867
org study id: 17915A
nct id: NCT03766867
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to evaluate the efficacy and safety of vortioxetine given as a
      single intravenous dose of 25 mg at initiation of an oral vortioxetine regimen of 10 mg/day
      for 7 days
The study consists of a 7-day double-blind Treatment Period (Day 0 to Day 6)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline (Day 0) to Day 1 (24 h post-infusion) in MADRS-6 subscale score
time frame: From baseline (Day 0) to Day 1 (24 h post-infusion)
description: The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The primary endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.
measure: Change from baseline (Day 0) to Day 3 in MADRS-6 subscale score
time frame: From baseline (Day 0) to Day 3
description: The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.
measure: Change from baseline (Day 0) to Day 7 in MADRS-6 subscale score
time frame: From baseline (Day 0) to Day 7
description: The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.
measure: Change in MADRS total score from baseline to Day 1, Day 3, Day 7
time frame: From baseline to Day 1, Day 3, Day 7
description: The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60.
measure: ≥50% decrease in MADRS total score from baseline on Day 1 and Day 3
time frame: On Day 1 and Day 3
description: The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60.
measure: CGI-I score at Day 1, Day 3, Day 7
time frame: At Day 1, Day 3, Day 7
description: The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.
measure: CGI-I response (defined as CGI-I score ≤2) on Day 1 and 3
time frame: At Day 1 and 3
description: The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.
measure: Change from baseline in CGI-S score to Day 1, Day 3, Day 7
time frame: From baseline to Day 1, Day 3, Day 7
description: The Clinical Global Impression (CGI) provides an overall clinician-determined summary measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI consists of two clinician-rated subscales: severity of illness (CGI-S) and global improvement (CGI-I). The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
measure: CL/F of vortioxetine
time frame: Day 0, Day 1, Day 7
description: Total plasma clearance of vortioxetine
measure: Cav
time frame: Day 0, Day 1, Day 7
description: average plasma concentration during a steady-state day
arm group label: Vortioxetine
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Vortioxetine infusion 25 mg
description: 1 mg/mL, concentrate for solution for infusion, 25 mL (25 mg) administered in 250 mL saline over 2 hours as single dose for 7 days
arm group label: Vortioxetine
intervention type: Drug
intervention name: Vortioxetine tablets 10 mg/day
description: 10 mg, tablets, oral administration once daily
arm group label: Vortioxetine
other name: Brintellix ®
intervention type: Drug
intervention name: Placebo infusion
description: concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose
arm group label: Placebo
intervention type: Drug
intervention name: Placebo tablets
description: oral administration once daily
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Email contact via H. Lundbeck A/S
role: Study Director
affiliation: LundbeckClinicalTrials@Lundbeck.com
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Bulgaria
country: Estonia
country: Latvia
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
mesh term: Vortioxetine