<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/NCT02228239</url>
  </required_header>
  <id_info>
    <org_study_id>CR104764</org_study_id>
    <secondary_id>2014-002005-38</secondary_id>
    <secondary_id>ESKETINTRD1006</secondary_id>
    <nct_id>NCT02228239</nct_id>
  </id_info>
  <brief_title>Study to Assess the Effects of Esketamine on Safety of On-road Driving in Healthy Participants</brief_title>
  <acronym>DRiVESaFe</acronym>
  <official_title>A Double-blind, Randomized, Placebo-Controlled, 3-way Crossover Study to Evaluate the Single Dose Effects of Intranasal Esketamine on Safety of On-Road Driving in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of esketamine compared to placebo on&#xD;
      driving performance as assessed by the mean difference of standard deviation of lateral&#xD;
      position (SDLP) from an on-road driving test in healthy participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, randomized (study medication assigned to participants by chance),&#xD;
      double-blind (neither Investigator nor participant knows which treatment the participant&#xD;
      receives), placebo-controlled (placebo is an inactive substance that is compared with a drug&#xD;
      to test whether the drug has a real effect in a clinical trial), single-center, single-dose&#xD;
      and 3-way crossover (the same medications provided to all participants but in different&#xD;
      sequence) study of esketamine in healthy participants. Participants will be randomly assigned&#xD;
      to 1 of 6 treatment sequences. The study will consist of 3 parts: Screening Phase (between 21&#xD;
      days and 1 day prior to the first dose administration), a 3-way crossover double-blind,&#xD;
      single dose treatment Phase (45 days) and follow-up Phase (7 to 10 days after last dose&#xD;
      administration). The maximum study duration for each participant will not exceed 7 weeks.&#xD;
      Participants will receive either Treatment A (esketamine 84 milligram (mg) intranasal and 1&#xD;
      placebo capsule), Treatment B (placebo intranasal and 1 mirtazapine 30 mg capsule) or&#xD;
      Treatment C (placebo intranasal and placebo capsule) in each treatment period. Driving&#xD;
      performance will be assessed primarily by the mean difference of SDLP from an on road driving&#xD;
      test. Participants' safety will be monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 1</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test</measure>
    <time_frame>4 to 14 hours post-dose</time_frame>
    <description>The SDLP will be measured from a validated on-road driving test in a 100 kilometer (km) highway-driving lane.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Standard Deviation of Speed (SDS) Assessed From an On-road Driving Test</measure>
    <time_frame>4 to 14 hours post-dose</time_frame>
    <description>The SDS will be measured from a validated on-road driving test in a 100 km highway-driving lane.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Speed (MS) Assessed From an On-road Driving Test</measure>
    <time_frame>4 to 14 hours post-dose</time_frame>
    <description>The MS will be measured from a validated on-road driving test in a 100 km highway-driving lane.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Lateral Position (MLP) Assessed From an On-road Driving Test</measure>
    <time_frame>4 to 14 hours post-dose</time_frame>
    <description>The MLP will be measured from a validated on-road driving test in a 100 km highway-driving lane.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Driving Performance Score</measure>
    <time_frame>After completion of driving test (4 to 14 hours post-dose)</time_frame>
    <description>Participants will indicate the perceived quality of their driving performance on a visual analog scale, which ranges from 0 ('I drove exceptionally poorly') to 20 ('I drove exceptionally well').</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Karolinska Sleepiness Scale (KSS) Score</measure>
    <time_frame>Pre-dose, 1, 2 hours and after completion of driving test (4 to 14 hours post-dose)</time_frame>
    <description>The KSS is a participant-reported assessment used to rate sleepiness on a scale of 1 to 9, ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Columbia Suicide Severity Rating Scale (C-SSRS) Score</measure>
    <time_frame>Up to 7 to 10 days after last dose administration</time_frame>
    <description>The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior developed to assess severity and track suicidal events providing a summary of both suicidal ideation and behavior to identify the level and type of suicidality present.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Psychiatric Rating Scale (BPRS) Symptom Sub-Scale Score</measure>
    <time_frame>Pre-dose, 1 and 2 hours post-dose</time_frame>
    <description>The BPRS is an 18-item rating scale which is used to assess a range of psychotic and affective symptoms rated from both observation of the participant and the participant's own report. Only the 4-item positive symptom subscale (consisting of: suspiciousness/persecution, hallucinations, unusual thought content, and conceptual disorganization) will be used and each question is rated on a 7-point scale ranging from 0 (not present) to 6 (extremely severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician Administered Dissociative States Scale (CADSS) Score</measure>
    <time_frame>Pre-dose, 1 and 2 hours post-dose</time_frame>
    <description>The CADSS is an instrument for the measurement of present-state dissociative symptoms. The CADSS comprises 23 subjective items, divided into 3 components: Depersonalization, Derealization and Amnesia. Participant's responses are coded on a 5-point scale (0 = &quot;Not at all&quot; through to 4 = &quot;Extremely&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>Pre-dose, 0.5, 1, 3 and 4 hours post-dose</time_frame>
    <description>The Cmax is the maximum observed plasma concentration of esketamine or noresketamine.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Sequence 1 (ABC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment A (esketamine 84 milligram (mg) intranasally and 1 placebo capsule) in Period 1, Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 2 and Treatment C (placebo intranasally and placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2 (BCA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 1, Treatment C (placebo intranasally and placebo capsule) in Period 2 and Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 3 (CAB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment C (placebo intranasally and placebo capsule) in Period 1, Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 2 and Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 4 (CBA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment C (placebo intranasally and placebo capsule) in Period 1, Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 2 and Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 5 (ACB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 1, Treatment C (placebo intranasally and placebo capsule) in Period 2 and Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 6 (BAC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 1, Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 2 and Treatment C (placebo intranasally and placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Esketamine</intervention_name>
    <description>Esketamine 84 milligram (mg) [3*1 of spray in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.</description>
    <arm_group_label>Sequence 1 (ABC)</arm_group_label>
    <arm_group_label>Sequence 2 (BCA)</arm_group_label>
    <arm_group_label>Sequence 3 (CAB)</arm_group_label>
    <arm_group_label>Sequence 4 (CBA)</arm_group_label>
    <arm_group_label>Sequence 5 (ACB)</arm_group_label>
    <arm_group_label>Sequence 6 (BAC)</arm_group_label>
    <other_name>JNJ-54135419</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mirtazapine</intervention_name>
    <description>Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.</description>
    <arm_group_label>Sequence 1 (ABC)</arm_group_label>
    <arm_group_label>Sequence 2 (BCA)</arm_group_label>
    <arm_group_label>Sequence 3 (CAB)</arm_group_label>
    <arm_group_label>Sequence 4 (CBA)</arm_group_label>
    <arm_group_label>Sequence 5 (ACB)</arm_group_label>
    <arm_group_label>Sequence 6 (BAC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (Matched to Esketamine)</intervention_name>
    <description>Placebo [3*1 in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.</description>
    <arm_group_label>Sequence 1 (ABC)</arm_group_label>
    <arm_group_label>Sequence 2 (BCA)</arm_group_label>
    <arm_group_label>Sequence 3 (CAB)</arm_group_label>
    <arm_group_label>Sequence 4 (CBA)</arm_group_label>
    <arm_group_label>Sequence 5 (ACB)</arm_group_label>
    <arm_group_label>Sequence 6 (BAC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (Matched to Mirtazapine)</intervention_name>
    <description>Placebo capsule will be administered orally on Day 1 in one of the treatment periods.</description>
    <arm_group_label>Sequence 1 (ABC)</arm_group_label>
    <arm_group_label>Sequence 2 (BCA)</arm_group_label>
    <arm_group_label>Sequence 3 (CAB)</arm_group_label>
    <arm_group_label>Sequence 4 (CBA)</arm_group_label>
    <arm_group_label>Sequence 5 (ACB)</arm_group_label>
    <arm_group_label>Sequence 6 (BAC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) (weight [kg]/height^2[m^2]) between 18 and 30 kg/m^2&#xD;
             (inclusive), and body weight not less than 45 kg&#xD;
&#xD;
          -  Blood pressure (after the participants is supine for 5 minutes) between 90 and 140&#xD;
             millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic&#xD;
             at Screening and pre-dose on Day 1 of Period 1&#xD;
&#xD;
          -  A woman of childbearing potential must have a negative urine pregnancy test at&#xD;
             Screening and pre-dose on Day 1 of Period 1&#xD;
&#xD;
          -  A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and&#xD;
             function at Screening and pre-dose on Day 1 of Period 1, including: sinus rhythm,&#xD;
             heart rate between 45 and 90 beats per minute (bpm), QTc interval less than or equal&#xD;
             to 450 milliseconds (ms), QRS interval of less than 120 ms, PR interval less than 200&#xD;
             ms and morphology consistent with healthy cardiac conduction and function 1st degree&#xD;
             AV block is exclusionary&#xD;
&#xD;
          -  Participant has a valid driving license for more than 3 years, has driven at least&#xD;
             5000 kilometer (km) in the past year and is driving a car regularly&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has clinically significant liver or renal insufficiency; cardiac,&#xD;
             vascular, pulmonary, gastrointestinal, endocrine, neurologic (including cataplexy and&#xD;
             cognitive impairment), hematologic, rheumatologic, psychiatric, or metabolic&#xD;
             disturbances. A significant primary sleep disorder is exclusionary&#xD;
&#xD;
          -  Clinically significant abnormal values for hematology, clinical chemistry, or&#xD;
             urinalysis at Screening, as deemed appropriate by the Investigator&#xD;
&#xD;
          -  Clinically significant abnormal physical examination, vital signs, or 12-lead&#xD;
             electrocardiogram (ECG) at Screening or on Day 1 of Period 1, as deemed appropriate by&#xD;
             the Investigator&#xD;
&#xD;
          -  Anatomical or medical conditions that may impede delivery or absorption of study&#xD;
             medication (for example, undergone facial reconstruction, rhinoplasty, significant&#xD;
             structural or functional abnormalities of the nose or upper airway; obstructions or&#xD;
             mucosal lesions of the nostrils or nasal passages; undergone sinus surgery in the&#xD;
             previous 2 years; or signs and symptoms of rhinitis predose on Day 1 of Period 1)&#xD;
&#xD;
          -  Has an abnormal or deviated nasal septum with any one or more of the following&#xD;
             symptoms: blockage of one or both nostrils, nasal congestion (especially 1-sided),&#xD;
             frequent nosebleeds, frequent sinus infections, and at times has facial pain,&#xD;
             headaches, and postnasal drip&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>December 29, 2014</last_update_submitted>
  <last_update_submitted_qc>December 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>Esketamine</keyword>
  <keyword>Mirtazapine</keyword>
  <keyword>Psychomotor.</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mirtazapine</mesh_term>
    <mesh_term>Esketamine</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/NCT02228239
org study id: CR104764
secondary id: 2014-002005-38
secondary id: ESKETINTRD1006
nct id: NCT02228239
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effect of esketamine compared to placebo on
      driving performance as assessed by the mean difference of standard deviation of lateral
      position (SDLP) from an on-road driving test in healthy participants.
This is a Phase 1, randomized (study medication assigned to participants by chance),
      double-blind (neither Investigator nor participant knows which treatment the participant
      receives), placebo-controlled (placebo is an inactive substance that is compared with a drug
      to test whether the drug has a real effect in a clinical trial), single-center, single-dose
      and 3-way crossover (the same medications provided to all participants but in different
      sequence) study of esketamine in healthy participants. Participants will be randomly assigned
      to 1 of 6 treatment sequences. The study will consist of 3 parts: Screening Phase (between 21
      days and 1 day prior to the first dose administration), a 3-way crossover double-blind,
      single dose treatment Phase (45 days) and follow-up Phase (7 to 10 days after last dose
      administration). The maximum study duration for each participant will not exceed 7 weeks.
      Participants will receive either Treatment A (esketamine 84 milligram (mg) intranasal and 1
      placebo capsule), Treatment B (placebo intranasal and 1 mirtazapine 30 mg capsule) or
      Treatment C (placebo intranasal and placebo capsule) in each treatment period. Driving
      performance will be assessed primarily by the mean difference of SDLP from an on road driving
      test. Participants' safety will be monitored throughout the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test
time frame: 4 to 14 hours post-dose
description: The SDLP will be measured from a validated on-road driving test in a 100 kilometer (km) highway-driving lane.
measure: Standard Deviation of Speed (SDS) Assessed From an On-road Driving Test
time frame: 4 to 14 hours post-dose
description: The SDS will be measured from a validated on-road driving test in a 100 km highway-driving lane.
measure: Mean Speed (MS) Assessed From an On-road Driving Test
time frame: 4 to 14 hours post-dose
description: The MS will be measured from a validated on-road driving test in a 100 km highway-driving lane.
measure: Mean Lateral Position (MLP) Assessed From an On-road Driving Test
time frame: 4 to 14 hours post-dose
description: The MLP will be measured from a validated on-road driving test in a 100 km highway-driving lane.
measure: Subjective Driving Performance Score
time frame: After completion of driving test (4 to 14 hours post-dose)
description: Participants will indicate the perceived quality of their driving performance on a visual analog scale, which ranges from 0 ('I drove exceptionally poorly') to 20 ('I drove exceptionally well').
measure: Karolinska Sleepiness Scale (KSS) Score
time frame: Pre-dose, 1, 2 hours and after completion of driving test (4 to 14 hours post-dose)
description: The KSS is a participant-reported assessment used to rate sleepiness on a scale of 1 to 9, ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep).
measure: Columbia Suicide Severity Rating Scale (C-SSRS) Score
time frame: Up to 7 to 10 days after last dose administration
description: The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior developed to assess severity and track suicidal events providing a summary of both suicidal ideation and behavior to identify the level and type of suicidality present.
measure: Brief Psychiatric Rating Scale (BPRS) Symptom Sub-Scale Score
time frame: Pre-dose, 1 and 2 hours post-dose
description: The BPRS is an 18-item rating scale which is used to assess a range of psychotic and affective symptoms rated from both observation of the participant and the participant's own report. Only the 4-item positive symptom subscale (consisting of: suspiciousness/persecution, hallucinations, unusual thought content, and conceptual disorganization) will be used and each question is rated on a 7-point scale ranging from 0 (not present) to 6 (extremely severe).
measure: Clinician Administered Dissociative States Scale (CADSS) Score
time frame: Pre-dose, 1 and 2 hours post-dose
description: The CADSS is an instrument for the measurement of present-state dissociative symptoms. The CADSS comprises 23 subjective items, divided into 3 components: Depersonalization, Derealization and Amnesia. Participant's responses are coded on a 5-point scale (0 = "Not at all" through to 4 = "Extremely").
measure: Maximum plasma concentration (Cmax)
time frame: Pre-dose, 0.5, 1, 3 and 4 hours post-dose
description: The Cmax is the maximum observed plasma concentration of esketamine or noresketamine.
arm group label: Sequence 1 (ABC)
arm group type: Experimental
description: Participants will receive Treatment A (esketamine 84 milligram (mg) intranasally and 1 placebo capsule) in Period 1, Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 2 and Treatment C (placebo intranasally and placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.
arm group label: Sequence 2 (BCA)
arm group type: Experimental
description: Participants will receive Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 1, Treatment C (placebo intranasally and placebo capsule) in Period 2 and Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.
arm group label: Sequence 3 (CAB)
arm group type: Experimental
description: Participants will receive Treatment C (placebo intranasally and placebo capsule) in Period 1, Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 2 and Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.
arm group label: Sequence 4 (CBA)
arm group type: Experimental
description: Participants will receive Treatment C (placebo intranasally and placebo capsule) in Period 1, Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 2 and Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.
arm group label: Sequence 5 (ACB)
arm group type: Experimental
description: Participants will receive Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 1, Treatment C (placebo intranasally and placebo capsule) in Period 2 and Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.
arm group label: Sequence 6 (BAC)
arm group type: Experimental
description: Participants will receive Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 1, Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 2 and Treatment C (placebo intranasally and placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.
intervention type: Drug
intervention name: Esketamine
description: Esketamine 84 milligram (mg) [3*1 of spray in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
arm group label: Sequence 1 (ABC)
arm group label: Sequence 2 (BCA)
arm group label: Sequence 3 (CAB)
arm group label: Sequence 4 (CBA)
arm group label: Sequence 5 (ACB)
arm group label: Sequence 6 (BAC)
other name: JNJ-54135419
intervention type: Drug
intervention name: Mirtazapine
description: Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.
arm group label: Sequence 1 (ABC)
arm group label: Sequence 2 (BCA)
arm group label: Sequence 3 (CAB)
arm group label: Sequence 4 (CBA)
arm group label: Sequence 5 (ACB)
arm group label: Sequence 6 (BAC)
intervention type: Drug
intervention name: Placebo (Matched to Esketamine)
description: Placebo [3*1 in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
arm group label: Sequence 1 (ABC)
arm group label: Sequence 2 (BCA)
arm group label: Sequence 3 (CAB)
arm group label: Sequence 4 (CBA)
arm group label: Sequence 5 (ACB)
arm group label: Sequence 6 (BAC)
intervention type: Drug
intervention name: Placebo (Matched to Mirtazapine)
description: Placebo capsule will be administered orally on Day 1 in one of the treatment periods.
arm group label: Sequence 1 (ABC)
arm group label: Sequence 2 (BCA)
arm group label: Sequence 3 (CAB)
arm group label: Sequence 4 (CBA)
arm group label: Sequence 5 (ACB)
arm group label: Sequence 6 (BAC)
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Mirtazapine
mesh term: Esketamine